NCT05030857

Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam 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 Midazolam, a Sensitive Index Substrate of CYP3A4, and to Assess the Effect of Food on the Pharmacokinetics of GLPG4716

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the effect of the administration of multiple doses of GLPG4716 on the amount of midazolam (MDZ) that gets into the blood when the two drugs are administered together compared to when midazolam is administered alone. Other objectives of this study are to evaluate the safety and tolerability of GLPG4716 when administered with midazolam and assess the amount of GLPG4716 that gets into the blood when administered with midazolam. This study will also assess the effect of food on the amount of GLPG4716 that gets into the blood.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG4716	From Day 3 to Day 14, participants will receive GLPG4716 tablets once daily in fasted state. On Day 8 GLPG4716 will be administered in fed state.
DRUG	Midazolam	On Days 1, 3 and 13, participants will receive a single oral dose of MDZ as an oral solution in fasted state.

Timeline

• Start date: 2021-09-08
• Primary completion: 2021-11-13
• Completion: 2021-11-13
• First posted: 2021-09-01
• Last updated: 2021-11-24

Locations

1 site across 1 country: Canada