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

NCT ID: NCT05677347

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-23
• Study Completion Date: 2023-07-20

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GSK3923868 500 mcg SD/Placebo SD/GSK3923868 1500 mcg RD

Eligible participants will receive a single dose (SD) of GSK3923868 500 microgram (mcg) in Treatment Period 1 followed by a single dose of placebo matching GSK3923868 in Treatment Period 2. Participants will also receive a repeat dose (RD) of GSK3923868 1500 mcg in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868.

Group Type: EXPERIMENTAL

GSK3923868

Intervention Type: DRUG

GSK3923868 will be administered

Placebo

Intervention Type: DRUG

Placebo will be administered

GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/Placebo RD

Eligible participants will receive a single dose of GSK3923868 500 mcg in Treatment Period 1 followed by a single dose of GSK3923868 1000 mcg in Treatment Period 2. Participants will also receive a repeat dose of placebo matching GSK3923868 in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868.

Group Type: EXPERIMENTAL

GSK3923868

Intervention Type: DRUG

GSK3923868 will be administered

Placebo

Intervention Type: DRUG

Placebo will be administered

GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD

Eligible participants will receive a single dose of GSK3923868 500 mcg in Treatment Period 1 followed by a single dose of GSK3923868 1000 mcg in Treatment Period 2. Participants will also receive repeat dose of GSK3923868 1500 mcg in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868.

Group Type: EXPERIMENTAL

GSK3923868

Intervention Type: DRUG

GSK3923868 will be administered

Placebo SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD

Eligible participants will receive a single dose of placebo matching GSK3923868 in Treatment Period 1 followed by a single dose of GSK3923868 1000 mcg in Treatment Period 2. Participants will also receive a repeat dose of GSK3923868 1500 mcg in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868.

Group Type: EXPERIMENTAL

GSK3923868

Intervention Type: DRUG

GSK3923868 will be administered

Placebo

Intervention Type: DRUG

Placebo will be administered

Interventions

GSK3923868

GSK3923868 will be administered

Intervention Type: DRUG

Placebo

Placebo will be administered

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Berlin, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

214075

Identifier Type: -

Identifier Source: org_study_id