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

• Status: Not yet recruiting
• Trial end date: 2023-05-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Albuterol; Norflurane

Criteria

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