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NCT Number: NCT06168318

A Study to Investigate the Relative Bioavailability and Food Effect of an Oral Capsid Inhibitor Tablet Formulation Compared With Other Oral Tablet Formulations in Male and Female Healthy Participants

This is a 3 part study of an investigational capsid inhibitor, VH4004280, in healthy adult participants. The purpose is to evaluate the effect of tablet formulation as well as food on bioavailability. Part 1 of the study will compare the relative bioavailability of VH4004280 Formulation A tablets to up to 4 alternative tablet formulations under fed (high fat) conditions. Part 2 of the study will assess the effect of fasted conditions on the bioavailability of VH4004280 Formulation A and alternative, optional formulations, relative to their respective bioavailability under fed conditions in Part 1. The optional Part 3 of the study will assess relative bioavailability of VH4004280 Formulation A to up to 3 alternative formulations, selected from Regimens B, C or D, under fed (lower fat) conditions.

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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

Nottingham, NG11 6JS, United Kingdom

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 55years of age.
  • Participants who are overtly healthy.
  • Negative (Severe Acute Respiratory Syndrome Coronavirus 2) SARs-CoV-2 test prior to dosing.
  • Has body mass index (BMI) within the range 19-32 (kg/m2).
  • Participants male at birth must use male condoms, and participants female at birth who are of childbearing potential must be using acceptable forms of birth control.
  • Capable of giving signed informed consent.

Exclusion criteria

  • History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
  • Abnormal blood pressure.
  • Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years.
  • Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition.
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities.
  • Participants with exclusionary electrocardiogram findings.
  • Past or intended use of exclusionary medications or vaccines.
  • Exposure > 4 new investigational products within 12 months, previous participation in this study, or current enrolment or participation in another investigational study.
  • ALT >1.5x upper limit of normal (ULN), total bilirubin >1.5x ULN, and/or estimated serum creatinine clearance <60 mL/min.
  • History of or current infection with hepatitis B or hepatitis C.
  • Positive SARS-CoV-2 test, having signs and symptoms suggestive of COVID-19, or contact with known COVID-19 positive person.
  • Positive HIV antibody test.
  • Participants with positive results for illicit drug use, regular use of drugs of abuse, tobacco or nicotine-containing product use, and/or excessive alcohol use.

Treatment and study plan

VH4004280 Formulation A

Drug

Oral administration of VH4004280 Formulation A in fasted or fed conditions.

VH4004280 Formulation B

Drug

Oral administration of VH4004280 Formulation B in fasted or fed conditions.

VH4004280 Formulation C

Drug

Oral administration of VH4004280 Formulation C in fasted or fed conditions.

VH4004280 Formulation D

Drug

Oral administration of VH4004280 Formulation D in fasted or fed conditions.

VH4004280 Formulation E

Drug

Oral administration of VH4004280 Formulation E in fasted or fed conditions.

Primary outcomes

  1. Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4004280 in fed conditions (after a high-fat or lower-fat meal)

    Time frame: From Day 1 to Day 49

  2. Area under the plasma drug concentration - time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tlast) of VH4004280 in fed conditions (after a high-fat or lower-fat meal)

    Time frame: From Day 1 to Day 49

  3. Maximum observed plasma drug concentration (Cmax) of VH4004280 in fed conditions(after a high-fat or lower-fat meal)

    Time frame: From Day 1 to Day 49

  4. Time to maximum observed plasma concentration (Tmax) of VH4004280 in fed conditions (after a high-fat or lower-fat meal)

    Time frame: From Day 1 to Day 49

Secondary outcomes

  1. Number of participants with AEs (Adverse Events), by severity

    Time frame: From Day 1 to Day 49

    An AE is any untoward medical occurrence in a participant or clinical investigation participant and can be any sign, symptom, or disease temporally associated with the use of a medicinal product. The severity scale is assessed as following: Grade 1 = mild symptoms causing no or minimal interference with usual social and functional activities with intervention not indicated. Grade 2 = moderate symptoms causing greater than minimal interference with usual social and functional activities with intervention indicated. Grade 3 = severe symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated. Grade 4 = potentially life-threatening symptoms causing inability to perform self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death.

  2. Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters

    Time frame: From Day 1 to Day 49

    The assessed laboratory assessments include Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase (ALP), direct bilirubin and total bilirubin, in both fed and fasted conditions.

  3. Change from baseline in liver panel parameters: Total bilirubin and direct bilirubin (micromoles per liter)

    Time frame: From Day 1 to Day 49

  4. Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter)

    Time frame: From Day 1 to Day 49

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Registry information

Official study title

A 3-part, Phase 1, Single-center, Open-label Study to Assess the Relative Bioavailability of Oral Formulations for an Investigational Capsid Inhibitor in Healthy Adult Participants, and to Evaluate the Effect of Food on Bioavailability for an Investigational Capsid Inhibitor in Healthy Adult Participants

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2023
Registry last updated
Aug 2, 2024

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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