Clinical trial NCT05677347: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Single ascending dose
Repeat dose
Phosphatidylinositol 4-kinase beta (PI4KB) inhibitor
Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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)
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Following Single Dose of GSK3923868
timeFrame: Up to 18 days
measure: Number of Participants With Non-SAEs and SAEs Following Repeat Dose of GSK3923868
timeFrame: Up to 29 days
measure: Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Single Dose of GSK3923868
timeFrame: Up to 18 days
measure: Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Repeat Dose of GSK3923868
timeFrame: Up to 29 days
measure: Number of Participants With Clinically Significant Changes in Urinalysis Parameters Following Repeat Dose of GSK3923868
timeFrame: Up to 29 days
measure: Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Single Dose of GSK3923868
timeFrame: Up to 18 days
measure: Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Repeat Dose of GSK3923868
timeFrame: Up to 29 days
measure: Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Single Dose of GSK3923868
timeFrame: Up to 18 days
measure: Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Repeat Dose of GSK3923868
timeFrame: Up to 29 days
Secondary outcomes:
measure: Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 24 Hours (AUC [0-24]) of GSK3923868 for Single Dose
timeFrame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
measure: 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
timeFrame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
measure: Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 6 Hours (AUC [0-6]) of GSK3923868 for Repeat Dose
timeFrame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3
measure: Maximum Observed Plasma Concentration (Cmax) of GSK3923868 for Single Dose
timeFrame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
measure: Time to Reach Cmax (Tmax) of GSK3923868 for Single Dose
timeFrame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
measure: Cmax of GSK3923868 for Repeat Dose
timeFrame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3
measure: Tmax of GSK3923868 for Repeat Dose
timeFrame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
References: