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Completed

NCT Number: NCT04263142

A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants

This is an open-label, 2 part, single-dose and crossover study conducted to assess the relative bioavailability of a tablet compared to a capsule of GSK3640254 and to assess the effect of food on the GSK3640254 tablet in healthy participants. This study will also evaluate the effect of food (fasted, moderate fat meal, and high fat meal) on the pharmacokinetics of the GSK3640254 mesylate tablet formulation. In Part 1, participants will be randomly assigned to 1 of 2 treatment sequences (AB or BA) in two sequential treatment periods; and in Part 2, participants will be randomly assigned to 1 of 3 treatment sequences (CDE, DEC, or ECD) in three sequential treatment periods. Participants will be randomized to receive a single dose of GSK3640254 200 milligram (mg) capsules under moderate fat conditions and GSK3640254 200 mg tablets under moderate fat, fasted and high fat conditions in each treatment period. Approximately 30 participants will be enrolled.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
  • Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
  • Body weight >=50.0 kilogram (kg) (110 pounds [lbs]) for men and >=45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 31.0 kg per square meter (kg/m^2) (inclusive).
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants: Males shall not engage in intercourse while confined in the clinic. There is no need for an extended period of double barrier use or prolonged abstinence after study discharge. Female participants: 1. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: a. not a woman of childbearing potential (WOCBP); or Is a WOCBP and using a nonhormonal contraceptive method that is highly effective, with a failure rate of <1 percent (%), for 28 days before intervention, during the intervention period, and for at least 28 days after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. 2. A WOCBP must have a negative highly sensitive serum pregnancy test at Screening and Day -1. 3. Additional requirements for pregnancy testing during and after study intervention.
  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions.

Exclusion criteria

  • Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A pre-existing condition interfering with normal gastrointestinal (GI) anatomy or motility (example [e.g.], gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study intervention or render the participant unable to take oral study intervention.
  • Prior cholecystectomy surgery (prior appendectomy is acceptable).
  • Any history of significant underlying psychiatric disorder, including, but not limited to, schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder.
  • Any history of major depressive disorder with or without suicidal features, or anxiety disorders that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment. Participants with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy (<6 months) without inpatient treatment and are currently well-controlled clinically or resolved may be considered for entry after discussion and agreement with the Medical Monitor.
  • Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the investigator (with or without psychiatric evaluation), could interfere with the participant's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the participant.
  • Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome.
  • Presence of hepatitis B surface antigen at Screening or within 3 months prior to starting study intervention.
  • Positive hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention and positive on reflex to hepatitis C ribonucleic acid (RNA).
  • Positive Human immunodeficiency virus (HIV)-1 and -2 antigen/antibody immunoassay at Screening.
  • ALT >1.5 times upper limit of normal (ULN). A single repeat of ALT is allowed within a single Screening period to determine eligibility.
  • Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). A single repeat of any laboratory abnormality is allowed within a single Screening period to determine eligibility.
  • Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
  • Any Grade 2 to 4 laboratory abnormality at Screening, with the exception of creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT (described above), will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single Screening period to determine eligibility.
  • A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine (indicating active current smoking) at Screening or before the first dose of study intervention.
  • Unable to refrain from the use of prescription or nonprescription drugs including vitamins, herbal and dietary supplements (including Saint John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study intervention and for the duration of the study.
  • Treatment with any vaccine within 30 days prior to receiving study intervention.
  • Unwillingness to abstain from excessive consumption of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their fruit juices within 7 days prior to the first dose of study intervention(s) until the end of the study.
  • Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the study intervention (whichever is longer).
  • Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 56 days.
  • Any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered Columbia Suicide Severity Rating Scale (C-SSRS).
  • Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction in the past 3 months, symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular tachycardia, second-degree atrioventricular block Mobitz Type II, third-degree atrioventricular block, complete heart block, or conduction abnormality) which, in the opinion of the investigator or Medical Monitor, will interfere with the safety for the individual participant.
  • Exclusion criteria for Screening ECG (a single repeat is allowed for eligibility determination): Heart rate: <50 or >100 beats per minute and QTcF interval: >450 millisecond.
  • History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 units. One unit is equivalent to 8 grams of alcohol: a half pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits.
  • Unable to refrain from tobacco or nicotine-containing products within 3 months prior to Screening.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.

Treatment and study plan

GSK3640254 Tablet

Drug

GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.

GSK3640254 Capsule

Drug

GSK3640254 capsules will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.

Primary outcomes

  1. Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) for GSK3640254-Part 1

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were calculated using standard non-compartmental analysis.

  2. Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Time t (AUC[0 to t]) for GSK3640254-Part 1

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

  3. Maximum Observed Concentration (Cmax) for GSK3640254-Part 1

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

  4. Time of Maximum Observed Concentration for GSK3640254-Part 1

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

  5. AUC(0 to Inf) for GSK3640254-Part 2

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

  6. AUC(0 to t) for GSK3640254-Part 2

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

  7. Cmax for GSK3640254-Part 2

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

  8. Time of Maximum Observed Concentration for GSK3640254-Part 2

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1

    Time frame: Up to Day 12

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

  2. Number of Participants With AEs and SAEs-Part 2

    Time frame: Up to Day 19

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

  3. Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets.

  4. Absolute Values for Erythrocytes Count-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: erythrocytes count.

  5. Absolute Values for Hemoglobin-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: hemoglobin.

  6. Absolute Values for Hematocrit-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: hematocrit.

  7. Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume.

  8. Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin.

  9. Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets.

  10. Absolute Values for Erythrocytes Count-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: erythrocytes count.

  11. Absolute Values for Hemoglobin-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: hemoglobin.

  12. Absolute Values for Hematocrit-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: hematocrit.

  13. Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume.

  14. Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin.

  15. Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  16. Change From Baseline in Erythrocytes Count-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  17. Change From Baseline in Hemoglobin-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  18. Change From Baseline in Hematocrit-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  19. Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  20. Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  21. Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  22. Change From Baseline in Erythrocytes Count-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  23. Change From Baseline in Hemoglobin-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  24. Change From Baseline in Hematocrit-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  25. Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  26. Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  27. Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate.

  28. Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide.

  29. Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH.

  30. Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein.

  31. Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase.

  32. Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate.

  33. Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide.

  34. Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH.

  35. Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein.

  36. Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase.

  37. Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  38. Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  39. Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  40. Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  41. Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  42. Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  43. Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  44. Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  45. Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  46. Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  47. Absolute Values for Urine Parameter: Specific Gravity-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density.

  48. Absolute Values for Urine Parameter: Urobilinogen-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen.

  49. Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Urine samples were collected at indicated time points for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0).

  50. Absolute Values for Urine Parameter: Specific Gravity-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density.

  51. Absolute Values for Urine Parameter: Urobilinogen-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen.

  52. Absolute Values for Urine Parameter: pH-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Urine samples were collected at indicated time points for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0).

  53. Change From Baseline in Urine Parameter: Specific Gravity-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  54. Change From Baseline in Urine Parameter: Urobilinogen-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  55. Change From Baseline in Urine Parameter: pH-Part 1

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Urine samples were collected at indicated time points for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  56. Change From Baseline in Urine Parameter: Specific Gravity-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  57. Change From Baseline in Urine Parameter: Urobilinogen-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  58. Change From Baseline in Urine Parameter: pH-Part 2

    Time frame: Baseline (Day -1), Day 2 and Day 5

    Urine samples were collected at indicated time points for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  59. Number of Participants With Abnormal Urine Dipstick Results-Part 1

    Time frame: Day 2 and Day 5

    Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented.

  60. Number of Participants With Abnormal Urine Dipstick Results-Part 2

    Time frame: Day 2 and Day 5

    Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented.

  61. Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1

    Time frame: Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5

    Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals.

  62. Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2

    Time frame: Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5

    Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals.

  63. Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1

    Time frame: Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5

    Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  64. Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2

    Time frame: Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5

    Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  65. Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  66. Absolute Values for Vital Sign: Pulse Rate-Part 1

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  67. Absolute Values for Vital Sign: Respiratory Rate-Part 1

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  68. Absolute Values for Vital Sign: Temperature-Part 1

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  69. Absolute Values for Vital Signs: DBP and SBP-Part 2

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  70. Absolute Values for Vital Sign: Pulse Rate-Part 2

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  71. Absolute Values for Vital Sign: Respiratory Rate-Part 2

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  72. Absolute Values for Vital Sign: Temperature-Part 2

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  73. Change From Baseline in Vital Signs: SBP and DBP-Part 1

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  74. Change From Baseline in Vital Sign: Pulse Rate-Part 1

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  75. Change From Baseline in Vital Sign: Respiratory Rate-Part 1

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  76. Change From Baseline in Vital Sign: Temperature-Part 1

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  77. Change From Baseline in Vital Signs: SBP and DBP-Part 2

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  78. Change From Baseline in Vital Sign: Pulse Rate-Part 2

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  79. Change From Baseline in Vital Sign: Respiratory Rate-Part 2

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  80. Change From Baseline in Vital Sign: Temperature-Part 2

    Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

    Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  81. Lag Time for Absorption (Tlag) for GSK3640254-Part 1

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

  82. Apparent Terminal Phase Half-life (t1/2) for GSK3640254-Part 1

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

  83. Apparent Oral Clearance (CL/F) for GSK3640254-Part 1

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

  84. Apparent Volume of Distribution (Vz/F) for GSK3640254-Part 1

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

  85. Plasma Concentration of GSK3640254-Part 1

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis.

  86. Tlag for GSK3640254-Part 2

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

  87. T1/2 for GSK3640254-Part 2

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

  88. CL/F for GSK3640254-Part 2

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

  89. Vz/F for GSK3640254-Part 2

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.

  90. Plasma Concentration of GSK3640254-Part 2

    Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

    Blood samples were collected at indicated time points for PK analysis.

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Registry information

Official study title

A Two-Part, Randomized, Open-Label, Single Dose, Crossover Clinical Trial to Assess the Relative Bioavailability of a Tablet Compared to a Capsule of GSK3640254 and to Assess the Effect of Food on the GSK3640254 Tablet in Healthy Participants

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2020
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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