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

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)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Placebo; Drug: GSK3923868

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: Placebo; Placebo will be administered; Drug: GSK3923868; GSK3923868 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: Placebo; Placebo will be administered; Drug: GSK3923868; GSK3923868 will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease (COPD); Single ascending dose; Repeat dose; Phosphatidylinositol 4-kinase beta (PI4KB) inhibitor
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 214075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No