drugset / Trial / NCT06625489

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

NCT06625489

Phase 1 Completed 50 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-10-07
Primary completion
2024-11-25
Completion
2024-11-25

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK3915393 Unknown
Subject Nintedanib Small molecule