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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05677347
Other study ID # 214075
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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