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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05677347
• Other study ID #: 214075
• Status: Completed
• Phase: Phase 1
• Start date: January 23, 2023
• Est. completion date: July 20, 2023

Study information

• Verified date: October 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 20, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• GSK3923868
GSK3923868 will be administered
• Placebo
Placebo will be administered

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs)		Up to Day 5 in treatment period 1 and 2
Primary	Number of participants with AEs and SAEs		Up to Day 28 in treatment period 3
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Maximum observed plasma concentration (Cmax) of GSK3923868 for single dose		Up to Day 2
Secondary	Time of occurrence of Cmax (Tmax) of GSK3923868 for single dose		Up to Day 2
Secondary	Cmax of GSK3923868 for repeat dose		Up to Day 14
Secondary	Tmax of GSK3923868 for repeat dose		Up to Day 14