Phase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05677347

Collaborator

(none)

Enrollment

Arms

7.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a two parts study, a single ascending dose followed by 14-days repeat dosing. The single ascending dose part will assess two dose levels of GSK3923868 or placebo across two treatment periods 1 and 2 in a single cohort of participants with a washout period of a minimum of 5 days after each treatment periods. The repeat dose part will assess repeated one dose level of GSK3923868 or placebo in treatment period 3 with up to 14 days of follow up in the same cohort of participants. The duration of study participation for treatment period 1, 2 and 3 will be 6, 6 and up to 29 days (including follow up), respectively.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: GSK3923868 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

The same cohort of participants will move from Part 1 (single ascending doses treatment periods 1 and 2) to Part 2 (repeat dose treatment period 3)The same cohort of participants will move from Part 1 (single ascending doses treatment periods 1 and 2) to Part 2 (repeat dose treatment period 3)

Masking:

Double (Participant, Investigator)

Masking Description:

The participants and investigators will be blinded.

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Placebo Controlled, Single and Repeat Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Inhaled GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Anticipated Study Start Date :

Jan 13, 2023

Anticipated Primary Completion Date :

Aug 18, 2023

Anticipated Study Completion Date :

Aug 18, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: GSK3923868 or placebo Participants allocation to GSK3923868 and placebo will be in 3:1 ratio. In treatment period 1, participants will receive GSK3923868 (Dose 1) or Placebo; in treatment period 2, GSK3923868 (Dose 2) or Placebo. There will be a washout period of at least 5 days after each treatment periods.	Drug: GSK3923868 GSK3923868 will be administered Drug: Placebo Placebo will be administered
Experimental: Part 2: GSK3923868 or placebo Participants from Part 1 will be allocated to GSK3923868 and placebo in 3:1 ratio to receive single repeat dose of GSK3923868 (Dose 3) or placebo for 14 days in treatment period 3 with up to 14 days of follow up.	Drug: GSK3923868 GSK3923868 will be administered Drug: Placebo Placebo will be administered

Arm

Intervention/Treatment

Experimental: Part 1: GSK3923868 or placebo

Participants allocation to GSK3923868 and placebo will be in 3:1 ratio. In treatment period 1, participants will receive GSK3923868 (Dose 1) or Placebo; in treatment period 2, GSK3923868 (Dose 2) or Placebo. There will be a washout period of at least 5 days after each treatment periods.

Drug: GSK3923868

GSK3923868 will be administered

Drug: Placebo

Placebo will be administered

Experimental: Part 2: GSK3923868 or placebo

Participants from Part 1 will be allocated to GSK3923868 and placebo in 3:1 ratio to receive single repeat dose of GSK3923868 (Dose 3) or placebo for 14 days in treatment period 3 with up to 14 days of follow up.

Drug: GSK3923868

GSK3923868 will be administered

Drug: Placebo

Placebo will be administered

Outcome Measures

Primary Outcome Measures

Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs) [Up to Day 5 in treatment period 1 and 2]
Number of participants with AEs and SAEs [Up to Day 28 in treatment period 3]
Number of participants with clinically significant changes in laboratory values, vital signs,12-lead Electrocardiogram (ECG) and spirometry measurements up to Follow Up [Up to Day 5 in treatment period 1 and 2]
Number of participants with clinically significant changes in laboratory values, vital signs, ECG and spirometry measurements up to Follow Up [Up to Day 28 in treatment period 3]

Secondary Outcome Measures

Area under the plasma-concentration time Curve from time zero (pre-dose) to 24 hours [AUC (0-24)] of GSK3923868 for single dose [Up to 24 hours post dose]
Area under the plasma-concentration time Curve from time zero (pre-dose) to time of the last quantifiable concentration [AUC(0-t)] of GSK3923868 for single dose [Up to 24 hours post dose]
Area under the plasma-concentration time Curve from time zero (pre-dose) to 6 hours [AUC (0-6)] of GSK3923868 for repeat dose [Up to 6 hours post dose]
Maximum observed plasma concentration (Cmax) of GSK3923868 for single dose [Up to Day 2]
Time of occurrence of Cmax (Tmax) of GSK3923868 for single dose [Up to Day 2]
Cmax of GSK3923868 for repeat dose [Up to Day 14]
Tmax of GSK3923868 for repeat dose [Up to Day 14]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Between 40 and 70 years of age.
Confirmed diagnosis of COPD for greater than (>) 6 months.
Participant is a smoker or an ex-smoker with a smoking history of at least 10 pack years.
A female participant is eligible to participate if she is not pregnant or breastfeeding and agrees to use contraceptives during the study (for women of childbearing potential only).

Exclusion Criteria:

Participant has poorly controlled or unstable COPD.
Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled.
Participant has had a respiratory tract infection treated with antibiotics within 4 weeks prior to screening.
Participant requires regular treatment with oral corticosteroids or has received a course of oral or parenteral corticosteroids within 4 weeks prior to screening.
Participant requires long-term oxygen therapy.
Current enrolment or past participation in a clinical trial within 30 days before this study starts.
Positive tests for human immunodeficiency virus (HIV), hepatitis B and C, or Coronavirus disease-19 (COVID-19).
Positive pre-study drug (except for as results of opioids prescribed for medical reasons and/or inadvertent consumption of poppy seeds) /alcohol screening result.