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
NCT ID: NCT06433908
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2024-06-04
2024-10-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1: Salbutamol 200 μg
Participants will receive single 200 μg doses given as 2x100 μg (ex-valve) at 20-second intervals. The intervention period will be 10 days with dosing with either HFA-152a or HFA-134a on Day 1, Day 4, Day 7, and Day 10.
Salbutamol HFA-152a
100 µg (ex-valve), given at 20-second intervals.
Salbutamol HFA-134a
100 µg (ex-valve), given at 20-second intervals.
Cohort 2: Salbutamol 800 μg
Participants will receive single 800 μg doses given as 8x100 μg (ex-valve) at 20-second intervals. The intervention period will be 10 days with dosing with either HFA-152a or HFA-134a on Day 1, Day 4, Day 7, and Day 10.
Salbutamol HFA-152a
100 µg (ex-valve), given at 20-second intervals.
Salbutamol HFA-134a
100 µg (ex-valve), given at 20-second intervals.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Salbutamol HFA-152a
100 µg (ex-valve), given at 20-second intervals.
Salbutamol HFA-134a
100 µg (ex-valve), given at 20-second intervals.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age: 18 to 55 years inclusive.
3. Weight: 45 to 110 kg inclusive
4. Status: healthy participants.
5. Females must not be pregnant or lactating.
6. 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.
7. 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.
8. 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.
9. 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.
10. Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the investigator.
11. Serum potassium and serum glucose levels within reference ranges of the clinical research center.
12. Willing and able to sign the informed consent form.
13. Spirometry at screening demonstrating forced expiratory volume ≥80% predicted.
Exclusion Criteria
2. History or presence of any form of asthma, including childhood asthma and exercise induced asthma.
3. At screening, systolic blood pressure \<90 mmHg or \>140 mmHg, or diastolic blood pressure \<50 mmHg or \>90 mmHg.
4. History of pathological tachycardia, or a pulse rate \> 85 beats per minute (bpm) at screening or Day-1.
5. 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.
6. Breast cancer within the past 10 years.
7. A QTcF value of \>450 msec at screening based on a triplicate measurement taken at a single timepoint.
8. Vaccine(s) within 2 weeks prior to admission, or plans to receive such vaccines during the study.
9. 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.
10. 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.
11. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
12. Presence of hepatitis B surface antigen at screening or within 3 months prior to first dose of study intervention.
13. 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.
14. Positive pre-study drug/alcohol screen, including tetrahydrocannabinol.
15. Positive HIV antibody test.
16. Cotinine levels indicative of smoking or history or use of tobacco- or nicotine containing products within 6 months prior to screening.
Assessment as ineligible by the investigator based on the results of the clinical laboratory tests or other assessments.
17. Average intake of more than 24 units of alcohol per week: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
18. Regular use of known drugs of abuse, including tetrahydrocannabinol.
19. Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to "vape" within 6 months prior to screening.
20. Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.).
21. Impairment which would prevent the correct and consistent use of an MDI, as determined by the investigator/delegate.
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Groningen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-508279-36-00
Identifier Type: OTHER
Identifier Source: secondary_id
219728
Identifier Type: -
Identifier Source: org_study_id