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Completed

NCT Number: NCT05791565

Green (Sustainable) VENTOLIN - Pharmacokinetics (PK) Study in Healthy Participants

This study will be conducted to compare the PK of salbutamol administered via metered dose inhalers (MDI) containing propellants 1,1-difluroethane (HFA-152a) and 1,1,1,2-tetrafluoroethane (HFA-134a) in healthy participants.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18 to 55 years, inclusive, at screening
  • Body mass index 18.0 to 30.0 kilograms per meter square (kg/m^2), inclusive, at screening
  • Weight: greater than or equal to (>=)50 kg
  • At screening, females must not be pregnant or lactating, or of non-childbearing potential
  • Female participants of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception
  • Male participants, if not surgically sterilized, must agree to use adequate contraception
  • Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, electrocardiogram, and vital signs, as judged by the investigator
  • Willing and able to sign the informed consent form

Exclusion criteria

  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
  • History or presence of any form of asthma, including childhood asthma and exercise induced asthma
  • Current enrollment or past participation in this clinical study
  • Participants with clinically significant abnormalities
  • A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse
  • Positive nasopharyngeal polymerase chain reaction test for severe acute respiratory syndrome-corona virus type 2 (SARS-CoV-2) on Day -1 or any known close contact with a person who tested positive for SARS-CoV-2 or with a coronavirus disease 2019 participant within 2 weeks prior to admission
  • Impairment which would prevent the correct and consistent use of an MDI, as determined by the investigator

Treatment and study plan

Salbutamol HFA-152a

Drug

Salbutamol HFA-152a will be administered.

Salbutamol HFA-134a

Drug

Salbutamol HFA-134a will be administered.

Primary outcomes

  1. Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol

    Time frame: Pre-dose and post dose 3, 5, 10, 15, 20 and 30 minutes on Day 1 and Day 4

    Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

  2. AUC From Time 0 to Infinity (AUC[0-inf]) of Salbutamol

    Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4

    Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

  3. AUC From Time 0 to Time t (AUC[0-t]) of Salbutamol

    Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4

    Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

  4. Maximum Observed Plasma Concentration (Cmax) of Salbutamol

    Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4

    Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

Secondary outcomes

  1. Time to Cmax (Tmax) of Salbutamol

    Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4

    Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

  2. Apparent Terminal Phase Half-life (t1/2) of Salbutamol

    Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4

    Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

  3. Minimum Observed Serum Potassium Level (Emin, K) After Dosing of Salbutamol

    Time frame: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)

    Minimum observed concentration of potassium levels after dose are presented.

  4. Weighted Mean Serum Potassium (0-4 Hour) (AUEC, K)

    Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)

    Weighed mean of serum potassium was calculated as summation of each interval. Each interval calculated as: (C2-C1)/2 * (t2-t1), where C2 and t2 are serum potassium and timepoint at the end of each interval, and C1 and t1 are serum potassium and timepoint at the start of each interval.

  5. Maximum Observed Heart Rate (Emax, HR) After Dosing of Salbutamol

    Time frame: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)

    Maximum observed heart rate (HR) after dose is presented.

  6. Weighted Mean Heart Rate (0-4 Hour) (AUEC, HR)

    Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)

    Weighed mean of HR was calculated as summation of each interval. Each interval calculated as: (C2-C1)/2 * (t2-t1), where C2 and t2 are HR and timepoint at the end of each interval, and C1 and t1 are HR and timepoint at the start of each interval.

  7. Maximum Observed QTcF (Emax, QTcF) After Dosing of Salbutamol

    Time frame: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)

    Maximum observed QTcF after dose are presented.

  8. Weighted Mean QTcF (0-4 Hour) (AUEC, QTcF)

    Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)

    Weighed mean of QTcF was calculated as summation of each interval. Each interval calculated as: [(C2+C1)/2×(t2-t1)]/Total time (Tlast-Tfirst, ie 4-0 hour) where C2 and t2 are concentration and timepoint at the end of each interval, and C1 and t1 are concentration and timepoint at the start of each interval. Tlast is the end of the last collection interval, and Tfirst is the start of the first collection interval.

  9. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 5 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pre-treatment or worsens relative to the pre-treatment state. SAE is defined as 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 disability/incapacity or is a congenital anomaly/birth defect. A summary of number of participants with any AEs and SAEs are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).

  10. Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval

    Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

    A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline is defined as the last observation recorded before the first study drug administration in each dosing period.

  11. Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval

    Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

    A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements.

  12. Absolute Values of ECG Parameter: Heart Rate

    Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

    A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements.

  13. Change From Baseline in ECG Parameters: Heart Rate

    Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

    A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements.

  14. Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count

    Time frame: On Day -1 (admission) and Day 5 (Discharge)

    Blood samples were collected for analyzing absolute values of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.

  15. Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count

    Time frame: On Day -1 (admission) and Day 5 (Discharge)

    Blood samples were collected for analyzing absolute values of red blood cell (RBC) and reticulocytes count.

  16. Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)

    Time frame: On Day -1 (admission) and Day 5 (Discharge)

    Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV).

  17. Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)

    Time frame: On Day -1 (admission) and Day 5 (Discharge)

    Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH).

  18. Absolute Values of Hematology Parameter: Hemoglobin

    Time frame: On Day -1 (admission) and Day 5 (Discharge)

    Blood samples were collected for analyzing absolute values of Hemoglobin.

  19. Absolute Values of Hematology Parameter: Hematocrit

    Time frame: On Day -1 (admission) and Day 5 (Discharge)

    Blood samples were collected for analyzing absolute values of Hematocrit.

  20. Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)

    Time frame: On Day -1 (admission) and Day 5 (Discharge)

    Blood samples were collected for analyzing absolute values of Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK).

  21. Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine

    Time frame: On Day -1 (admission) and Day 5 (Discharge)

    Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin and Creatinine.

  22. Absolute Values of Clinical Chemistry Parameter: Total Protein

    Time frame: On Day -1 (admission) and Day 5 (Discharge)

    Blood samples were collected for analyzing absolute values of Total protein.

  23. Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)

    Time frame: On Day -1 (admission) and Day 5 (Discharge)

    Blood samples were collected for analyzing absolute values of Calcium, Sodium, Potassium, Blood Urea Nitrogen.

  24. Absolute Values for Chemistry Parameter: Glucose

    Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

    Blood samples were collected for analyzing absolute values of glucose.

  25. Number of Participants With Urinalysis Parameters by Dipstick Method

    Time frame: On Day -1 (admission) and Day 5 (Discharge)

    Urine samples were collected to assess glucose, ketones, occult blood, protein, urobilinogen and bilirubin by dipstick method. The dipstick test gave results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Results are presented as'(+)' indicating 'equivocal', '+' indicating 'trace amount', '++' indicating 'positive', and 'negative'.

  26. Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

    Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

    Blood pressure measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.

  27. Absolute Values of Pulse Rate

    Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

    Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Single Dose Two-way Cross-over Study in Healthy Participants to Compare the Pharmacokinetics (PK) of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a and HFA-134a

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2023
Registry last updated
Sep 23, 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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