Phase 1
Completed N=12
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
Source: ClinicalTrials.gov NCT05677347 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Following Single Dose of GSK3923868 — 1; 2; 1; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Following Single Dose of GSK3923868 |
1; 2; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Non-SAEs and SAEs Following Repeat Dose of GSK3923868 |
2; 4; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Single Dose of GSK3923868 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Repeat Dose of GSK3923868 |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Urinalysis Parameters Following Repeat Dose of GSK3923868 |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Single Dose of GSK3923868 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Repeat Dose of GSK3923868 |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Single Dose of GSK3923868 |
0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Repeat Dose of GSK3923868 |
0; 0 | — |
| SECONDARY Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 24 Hours (AUC [0-24]) of GSK3923868 for Single Dose |
23463.81; 46553.52 | — |
| 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 |
23443.19; 46519.91 | — |
| SECONDARY Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 6 Hours (AUC [0-6]) of GSK3923868 for Repeat Dose |
42593.74; 40787.96 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of GSK3923868 for Single Dose |
4823.19; 10042.80 | — |
| SECONDARY Time to Reach Cmax (Tmax) of GSK3923868 for Single Dose |
1.00; 1.00 | — |
| SECONDARY Cmax of GSK3923868 for Repeat Dose |
14081.13; 13854.60 | — |
| SECONDARY Tmax of GSK3923868 for Repeat Dose |
0.95; 1.00 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05677347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.