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

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Part A: Placebo	Placebo will be administered.
DRUG	Nintedanib	Nintedanib will be administered.
DRUG	GSK3915393	GSK3915393 will be administered.

Timeline

• Start date: 2024-10-07
• Primary completion: 2024-11-25
• Completion: 2024-11-25
• First posted: 2024-10-03
• Last updated: 2025-02-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study