NCT02562950

A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects

A Phase I, Open Interaction Study Between Oral Doses of GLPG1837 and Single Doses of Midazolam in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with GLPG1837, after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day 11). Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with midazolam in healthy male subjects will be evaluated. A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.) GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg (500 mg b.i.d.) GLPG1837.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG1837 500 mg	Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12.
DRUG	Midazolam	Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
DRUG	GLPG1837 1000 mg	Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12.

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-09-29
• Last updated: 2015-10-23

Locations

1 site across 1 country: Belgium