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

NCT05791565 | Completed Phase 1 Results

• 1 other identifier: 219430
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

Cross-over; Healthy volunteers; Salbutamol; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

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

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

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

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

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

  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

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

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

  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

• Maximum Observed Plasma Concentration (Cmax) of Salbutamol

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

  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

Secondary Outcomes (27)

• Time to Cmax (Tmax) of Salbutamol

  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

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

  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

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

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

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

  Pre-dose and 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 (Emax, HR) After Dosing of Salbutamol

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

Study Arms (2)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Interventions

Salbutamol HFA-152a DRUG

Salbutamol HFA-152a will be administered.

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

Salbutamol HFA-134a DRUG

Salbutamol HFA-134a will be administered.

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Groningen, 9728 NZ, Netherlands

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This will be a double-blind study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a 2-way cross-over study.

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start: April 3, 2023
• Primary Completion: May 21, 2023
• Study Completion: May 21, 2023
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

NL (1)