Phase 1
N=30
A Study to Compare the Pharmacokinetics (PK) of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152A (Test) or HFA-134A (Reference) in Healthy Participants Aged 18 to 55 Inclusive
Asthma · Healthy Participants
Bottom Line
View on ClinicalTrials.gov: NCT06433908 ↗Enrolled (actual)
30
Serious AEs
0.8%
Results posted
Jan 2026
Primary outcome: Primary: Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30]) — 156.41; 162.11 Hour * Picogram per Milliliter (h*pg/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Salbutamol HFA-152a (Drug); Salbutamol HFA-134a (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30]) |
156.41; 162.11 | — |
| PRIMARY Cohort 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity]) |
5734.92; 4431.63 | — |
| PRIMARY Cohort 1: Maximum Observed Plasma Concentration (Cmax) |
639.28; 518.51 | — |
| PRIMARY Cohort 2: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30]) |
443.33; 467.88 | — |
| PRIMARY Cohort 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity]) |
17098.45; 14210.59 | — |
| PRIMARY Cohort 2: Maximum Observed Plasma Concentration (Cmax) |
1891.30; 1677.79 | — |
| SECONDARY Cohort 1: Time to Reach Cmax (Tmax) |
2.00; 2.0; 1.25; 1.00; 1.50; 1.50 | — |
| SECONDARY Cohort 1: Apparent Terminal Phase Half-life (t1/2) |
7.83; 7.50; 7.62; 7.43; 7.92; 7.35 | — |
| SECONDARY Cohort 1: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last]) |
5120.73; 3977.02 | — |
| SECONDARY Cohort 1-Intra-Participant Variability of AUC (0-30min) |
36.3; 28.7 | — |
| SECONDARY Cohort 1: Intra Participant Variability of AUC (0-infinity) |
28.3; 18.6 | — |
| SECONDARY Cohort 1: Intra Participant Variability of AUC(0-last) |
28.5; 18.3 | — |
| SECONDARY Cohort 1: Intra Participant Variability of Cmax |
33.5; 17.3 | — |
| SECONDARY Cohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
18; 12; 1; 0 | — |
| SECONDARY Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) |
55.1; 52.7; 63.1; 62.6; 53.6; 55.0 | — |
| SECONDARY Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals |
403.0; 411.6; 396.4; 402.4; 411.9; 399.0 | — |
| SECONDARY Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR |
8.0; 10.0; 8.6; 7.8; 12.5; 5.7 | — |
| SECONDARY Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals |
-6.6; -9.2; -11.5; -5.9; -8.9; -7.5 | — |
| SECONDARY Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count |
3.62; 3.32; 3.05; 2.95; 2.07; 1.97 | — |
| SECONDARY Cohort 1: Absolute Values of Hematology Parameter: Erythrocytes |
4.890; 5.158; 4.516; 4.753 | — |
| SECONDARY Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) |
91.1; 92.1; 90.0; 91.6 | — |
| SECONDARY Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) |
1.817; 1.845; 1.823; 1.841 | — |
| SECONDARY Cohort 1: Absolute Values of Hematology Parameter: Hemoglobin |
143.19; 153.08; 132.77; 140.94 | — |
| SECONDARY Cohort 1: Absolute Values of Hematology Parameter: Hematocrit |
0.445; 0.475; 0.405; 0.433 | — |
| SECONDARY Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) |
21.67; 23.22; 19.33; 21.45; 65.4; 73.1 | — |
| SECONDARY Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine |
4.12; 4.85; 3.79; 4.15; 12.2; 16.3 | — |
| SECONDARY Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen |
2.388; 2.431; 2.300; 2.306; 139.7; 139.7 | — |
| SECONDARY Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium |
4.76; 4.89; 4.97; 4.60; 4.86; 4.71 | — |
| SECONDARY Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
108.6; 111.9; 109.9; 113.9; 112.2; 115.9 | — |
| SECONDARY Cohort 1: Absolute Values of Pulse Rate (PR) |
55.7; 51.1; 63.9; 65.3; 61.9; 63.6 | — |
| SECONDARY Cohort 2: Time to Reach Cmax (Tmax) |
1.50; 1.25; 1.50; 1.50; 1.50; 1.50 | — |
| SECONDARY Cohort 2: Apparent Terminal Phase Half-life (t1/2) |
8.56; 7.73; 7.65; 7.79; 7.61; 7.57 | — |
| SECONDARY Cohort 2: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last]) |
15345.11; 12840.80 | — |
| SECONDARY Cohort 2-Intra-Participant Variability of AUC (0-30min) |
22.9; 25.8 | — |
| SECONDARY Cohort 2: Intra Participant Variability of AUC (0-infinity) |
10.0; 8.6 | — |
| SECONDARY Cohort 2: Intra Participant Variability of AUC (0-last) |
10.4; 9.0 | — |
| SECONDARY Cohort 2: Intra Participant Variability of Cmax |
14.1; 12.2 | — |
| SECONDARY Cohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
20; 21; 0; 0 | — |
| SECONDARY Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) |
63.9; 53.2; 75.9; 66.4; 54.5; 61.4 | — |
| SECONDARY Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals |
407.8; 399.9; 400.8; 402.9; 398.9; 401.9 | — |
| SECONDARY Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR |
12.0; 13.2; 12.2; 15.0; 11.6; 11.1 | — |
| SECONDARY Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals |
-7.0; 3.0; 0.7; 0.0; 2.6; 5.1 | — |
| SECONDARY Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count |
4.56; 3.11; 4.20; 2.81; 2.17; 2.01 | — |
| SECONDARY Cohort 2: Absolute Values of Hematology Parameter: Erythrocytes |
5.028; 5.038; 4.575; 4.826 | — |
| SECONDARY Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) |
89.8; 91.3; 90.3; 91.4 | — |
| SECONDARY Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) |
1.834; 1.851; 1.837; 1.853 | — |
| SECONDARY Cohort 2: Absolute Values of Hematology Parameter: Hemoglobin |
148.25; 149.95; 134.99; 143.73 | — |
| SECONDARY Cohort 2: Absolute Values of Hematology Parameter: Hematocrit |
0.450; 0.458; 0.412; 0.440 | — |
| SECONDARY Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) |
19.15; 23.88; 21.22; 25.63; 64.1; 62.6 | — |
| SECONDARY Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine |
3.75; 4.68; 3.58; 4.18; 16.7; 16.1 | — |
| SECONDARY Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen |
2.422; 2.388; 2.313; 2.341; 138.8; 139.1 | — |
| SECONDARY Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium |
4.84; 4.99; 5.04; 4.96; 5.08; 4.96 | — |
| SECONDARY Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
109.9; 108.3; 114.9; 113.8; 114.6; 113.8 | — |
| SECONDARY Cohort 2: Absolute Values of Pulse Rate (PR) |
62.1; 51.3; 75.8; 67.7; 75.8; 64.0 | — |
Summary
The primary objective of the study is to characterize the PK of single doses of salbutamol in healthy participants delivered via an MDI containing propellant HFA-152a (test), and to compare with an MDI containing propellant HFA-134a (reference).
Eligibility Criteria
Inclusion Criteria
- Sex: male or female; females may be of childbearing potential, of nonchild bearing potential, or postmenopausal.
- Age: 18 to 55 years inclusive.
- Weight: 45 to 110 kg inclusive
- Status: healthy participants.
- Females must not be pregnant or lactating.
- All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research center based on investigator judgment. An exception is made for hormonal contraceptives, which may be used throughout the study.
- All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) must have been stopped at least 14 days prior to admission to the clinical research center based on investigator judgment. An exception is made for acetaminophen, which is allowed up to admission to the clinical research center.
- Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening, and from 48 hours (2 days) prior to admission until discharge from the clinical research center.
- Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to admission until discharge from the clinical research center.
- Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the investigator.
- Serum potassium and serum glucose levels within reference ranges of the clinical research center.
- Willing and able to sign the informed consent form.
- Spirometry at screening demonstrating forced expiratory volume ≥80% predicted.
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.
- History or presence of any form of asthma, including childhood asthma and exercise induced asthma.
- At screening, systolic blood pressure 140 mmHg, or diastolic blood pressure 90 mmHg.
- History of pathological tachycardia, or a pulse rate > 85 beats per minute (bpm) at screening or Day-1.
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years.
- A QTcF value of >450 msec at screening based on a triplicate measurement taken at a single timepoint.
- Vaccine(s) within 2 weeks prior to admission, or plans to receive such vaccines during the study.
- Donation or loss of more than 450 mL of blood within 60 days prior to (the first) drug administration. Donation or loss of more than 1.5 L of blood (for male participants) or more than 1.0 L of blood (for female participants) in the 10 months prior to (the first) drug administration in the current study.
- Participation in a drug study within 30 days prior to (the first) drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to (the first) drug administration in the current study.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Presence of hepatitis B surface antigen at screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. NOTE: Participants with positive hepatitis C antibody test result due to prior resolved disease can be enrolled if a confirmatory negative hepatitis C RNA test is obtained.
- Positive pre-study drug/alcohol screen, including tetrahydrocannabinol.
- Positive HIV antibody test.
- Cotinine levels indicative of smoking or history or use
Data sourced from ClinicalTrials.gov (NCT06433908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.