Last updated: 07/18/2024 08:30:13
Phase 1, single and repeat dose study to assess safety, tolerability, and pharmacokinetics (PK) of GSK3923868 in participants with Chronic Obstructive Pulmonary Disease (COPD)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to Day 5 in treatment period 1 and 2
Number of participants with AEs and SAEs
Timeframe: Up to Day 28 in treatment period 3
Number of participants with clinically significant changes in laboratory values, vital signs,12-lead Electrocardiogram (ECG) and spirometry measurements up to Follow Up
Timeframe: Up to Day 5 in treatment period 1 and 2
Number of participants with clinically significant changes in laboratory values, vital signs, ECG and spirometry measurements up to Follow Up
Timeframe: Up to Day 28 in treatment period 3
Secondary outcomes:
Area under the plasma-concentration time Curve from time zero (pre-dose) to 24 hours [AUC (0-24)] of GSK3923868 for single dose
Timeframe: Up to 24 hours post 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
Timeframe: Up to 24 hours post dose
Area under the plasma-concentration time Curve from time zero (pre-dose) to 6 hours [AUC (0-6)] of GSK3923868 for repeat dose
Timeframe: Up to 6 hours post dose
Maximum observed plasma concentration (Cmax) of GSK3923868 for single dose
Timeframe: Up to Day 2
Time of occurrence of Cmax (Tmax) of GSK3923868 for single dose
Timeframe: Up to Day 2
Cmax of GSK3923868 for repeat dose
Timeframe: Up to Day 14
Tmax of GSK3923868 for repeat dose
Timeframe: Up to Day 14
Interventions:
Enrollment:
12
Primary completion date:
2023-20-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
January 2023 to July 2023
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
40 - 70 Years
Accepts healthy volunteers
No
- Between 40 and 70 years of age.
- Confirmed diagnosis of COPD for greater than (>) 6 months.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2023-20-07
Actual study completion date
2023-20-07
Plain language summaries
Summary of results in plain language
Available language(s): English, German
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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