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

Asthma Clinical Trial

Official title:

A Single Dose Two-way Cross-over Study in Healthy Participants to Compare the Pharmacokinetics (PK) of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a and HFA-134a

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05791565
• Other study ID #: 219430
• Status: Completed
• Phase: Phase 1
• Start date: April 3, 2023
• Est. completion date: May 21, 2023

Study information

• Verified date: November 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 21, 2023
• Est. primary completion date: May 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Salbutamol HFA-152a
Salbutamol HFA-152a will be administered.
• Salbutamol HFA-134a
Salbutamol HFA-134a will be administered.

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve (AUC) up to 30 minutes post-dose (AUC[0-30 minute]) of salbutamol		Pre-dose and at 3, 5, 10, 15, 20 and 30 minutes post-dose on Days 1 and 4
Primary	AUC from time 0 to infinity (AUC[0-inf]) of salbutamol		Up to Day 5
Primary	AUC from time 0 to time t (AUC[0-t]) of salbutamol		Up to Day 5
Primary	Maximum observed plasma concentration (Cmax) of salbutamol		Up to Day 5
Secondary	Time to Cmax (Tmax) of salbutamol		Up to Day 5
Secondary	Apparent terminal phase half-life (t1/2) of salbutamol		Up to Day 5
Secondary	Minimum serum potassium level following administration of salbutamol		Up to Day 5
Secondary	Weighted mean (0-4 hours) serum potassium level following administration of salbutamol		Pre-dose and at 15 minutes, 30 minutes, 1, 1.5, 2 and 4 hours post-dose on Days 1 and 4
Secondary	Maximum heart rate following administration of Salbutamol		Up to Day 5
Secondary	Weighted mean (0-4 hours) heart rate following administration of Salbutamol		Pre-dose and at 15 minutes, 30 minutes, 1, 1.5, 2 and 4 hours post-dose on Days 1 and 4
Secondary	Maximum corrected QT (QTc) interval following administration of Salbutamol		Up to Day 5
Secondary	Weighted mean (0-4 hours) QTc interval following administration of Salbutamol		Pre-dose and at 15 minutes, 30 minutes, 1, 1.5, 2 and 4 hours post-dose on Days 1 and 4
Secondary	Number of participants with non-serious adverse events and serious adverse events		Up to Day 5
Secondary	Absolute values of Electrocardiogram (ECG) parameters: PR interval, QRS duration, QT interval and corrected QT (QTc) interval (Milliseconds)		Up to Day 5
Secondary	Change from Baseline in ECG parameters: PR interval, QRS duration, QT interval and QTc interval (Milliseconds)		Baseline and up to Day 5
Secondary	Absolute values of ECG parameter: Heart rate (Beats per minute)		Up to Day 5
Secondary	Change from Baseline in ECG parameters: Heart rate (Beats per minute)		Baseline and up to Day 5
Secondary	Absolute values of hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count (Giga cells per liter)		Up to Day 5
Secondary	Absolute values of hematology parameter: Red blood cell (RBC) count (Trillion cells per liter)		Up to Day 5
Secondary	Absolute values of hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters)		Up to Day 5
Secondary	Absolute values of hematology parameter: Mean corpuscular hemoglobin (MCH) (Picograms)		Up to Day 5
Secondary	Absolute values of hematology parameter: Percentage of reticulocytes (Percentage of reticulocytes)		Up to Day 5
Secondary	Absolute values of hematology parameter: Hemoglobin (Grams per Liter)		Up to Day 5
Secondary	Absolute values of hematology parameter: Hematocrit (Proportion of red blood cells in blood)		Up to Day 5
Secondary	Absolute values of clinical chemistry parameters: Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK) (International units per Liter)		Up to Day 5
Secondary	Absolute values of clinical chemistry parameters: direct bilirubin, total bilirubin and Creatinine (Micromoles per liter)		Up to Day 5
Secondary	Absolute values of clinical chemistry parameter: Total protein (Grams per liter)		Up to Day 5
Secondary	Absolute Values for Chemistry Parameters: Glucose, Calcium, Sodium, Potassium, Blood Urea Nitrogen (Millimoles per liter)		Up to Day 5
Secondary	Number of participants with abnormal urinalysis parameters by Dipstick Method		Up to Day 5
Secondary	Absolute values of diastolic blood pressure (DBP) and systolic blood pressure (SBP) (Millimeters of mercury [mmHg])		Up to Day 5
Secondary	Absolute values of pulse rate (Beats per minute)		Up to Day 5