Back to resultsPhase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
GSK3923868
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Single ascending dose, Repeat dose, Phosphatidylinositol 4-kinase beta (PI4KB) inhibitor, Chronic Obstructive Pulmonary Disease (COPD)
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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part 1: GSK3923868 or placebo
Part 2: GSK3923868 or placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs
Number of participants with clinically significant changes in laboratory values, vital signs,12-lead Electrocardiogram (ECG) and spirometry measurements up to Follow Up
Number of participants with clinically significant changes in laboratory values, vital signs, ECG and spirometry measurements up to Follow Up
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
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
Area under the plasma-concentration time Curve from time zero (pre-dose) to 6 hours [AUC (0-6)] of GSK3923868 for repeat dose
Maximum observed plasma concentration (Cmax) of GSK3923868 for single dose
Time of occurrence of Cmax (Tmax) of GSK3923868 for single dose
Cmax of GSK3923868 for repeat dose
Tmax of GSK3923868 for repeat dose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05677347
Brief Title
Phase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
July 20, 2023 (Actual)
Study Completion Date
July 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Single ascending dose, Repeat dose, Phosphatidylinositol 4-kinase beta (PI4KB) inhibitor, Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
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)
Masking
ParticipantInvestigator
Masking Description
The participants and investigators will be blinded.
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1: GSK3923868 or placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2: GSK3923868 or placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GSK3923868
Intervention Description
GSK3923868 will be administered
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered
Primary Outcome Measure Information:
Title
Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Up to Day 5 in treatment period 1 and 2
Title
Number of participants with AEs and SAEs
Time Frame
Up to Day 28 in treatment period 3
Title
Number of participants with clinically significant changes in laboratory values, vital signs,12-lead Electrocardiogram (ECG) and spirometry measurements up to Follow Up
Time Frame
Up to Day 5 in treatment period 1 and 2
Title
Number of participants with clinically significant changes in laboratory values, vital signs, ECG and spirometry measurements up to Follow Up
Time Frame
Up to Day 28 in treatment period 3
Secondary Outcome Measure Information:
Title
Area under the plasma-concentration time Curve from time zero (pre-dose) to 24 hours [AUC (0-24)] of GSK3923868 for single dose
Time Frame
Up to 24 hours post dose
Title
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
Time Frame
Up to 24 hours post dose
Title
Area under the plasma-concentration time Curve from time zero (pre-dose) to 6 hours [AUC (0-6)] of GSK3923868 for repeat dose
Time Frame
Up to 6 hours post dose
Title
Maximum observed plasma concentration (Cmax) of GSK3923868 for single dose
Time Frame
Up to Day 2
Title
Time of occurrence of Cmax (Tmax) of GSK3923868 for single dose
Time Frame
Up to Day 2
Title
Cmax of GSK3923868 for repeat dose
Time Frame
Up to Day 14
Title
Tmax of GSK3923868 for repeat dose
Time Frame
Up to Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Phase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)
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