Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625489
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
A Study to Evaluate the Safety Tolerability and Blood Levels of GSK3915393 Administered to Healthy Participants of Chinese Japanese and European Ancestry and to Assess Effects of GSK3915393 on Nintedanib
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Placebo-Controlled Double-Blind Parallel Group Study to Evaluate the Safety Tolerability and Pharmacokinetics of GSK3915393 Administered as a Single Dose to Healthy Participants of Chinese Japanese and European Ancestry and to Assess the Effects of GSK3915393 on the Pharmacokinetics of Nintedanib
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
GSK3915393 is a new medicine which is being developed for a chronic lung disease called Idiopathic Pulmonary Fibrosis IPF This is a healthy participant study which has two parts Part A will assess the safety tolerability and blood levels of GSK3915393 given as a single dose to healthy participants of Chinese Japanese and European ancestries Part B is a drug-drug interaction DDI study that examines the effect of a single dose of GSK3915393 on the blood levels of a single dose of nintedanib which is an approved drug for IPF
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None