NCT04971746

Drug-drug Interaction Study with GLPG4716 and Nintedanib and Pirfenidone in Healthy Subjects

An Open-label, Fixed-sequence Drug-drug Interaction Study in Healthy Subjects to Evaluate the Effect of GLPG4716 on the Pharmacokinetics of Nintedanib and Pirfenidone

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main aim of this study is to investigate the possible effect of GLPG4716 on the pharmacokinetics (PK) of pirfenidone and nintedanib. Further aims are to investigate safety and tolerability of GLPG4716 alone or administered simultaneously with pirfenidone or nintedanib.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pirfenidone	On Days 1 and 13, participants will receive an oral dose of pirfenidone.
DRUG	GLPG4716	From Day 3 to Day 14, participants will receive GLPG4716 daily.
DRUG	Nintedanib	On Days 1 and 13, participants will receive an oral dose of nintedanib.

Timeline

• Start date: 2021-07-19
• Primary completion: 2022-05-09
• Completion: 2022-05-09
• First posted: 2021-07-21
• Last updated: 2024-09-19

Locations

1 site across 1 country: Germany