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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Salbutamol HFA-152a; Drug: Salbutamol HFA-134a

Study type: Interventional

Funder types: Industry

Identifiers

NCT05791565

219430

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Salbutamol HFA-152a MDI followed by Salbutamol HFA-134a MDI

Experimental group

Description:

Participants will receive Salbutamol HFA-152a MDI in treatment period 1 followed by Salbutamol HFA-134a MDI in treatment period 2. There will be a minimum washout period of 72 hours between each treatment period.

Treatment:

Drug: Salbutamol HFA-134a

Drug: Salbutamol HFA-152a

Salbutamol HFA-134a MDI followed by Salbutamol HFA-152a MDI

Experimental group

Description:

Participants will receive Salbutamol HFA-134a MDI in treatment period 1 followed by Salbutamol HFA-152a MDI in treatment period 2. There will be a minimum washout period of 72 hours between each treatment period.

Treatment:

Drug: Salbutamol HFA-134a

Drug: Salbutamol HFA-152a