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 — —