NCT02662452

First-in-Human Single and Multiple Dose of GLPG2222

Randomized, Double-blind, Placebo-controlled, First-in-Human Study of GLPG2222 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2). Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG2222 single dose	single ascending doses, oral suspension
DRUG	Placebo single dose	single doses, oral suspension, matching placebo
DRUG	GLPG2222 multiple doses	multiple ascending doses, daily for 14 days, oral suspension
DRUG	Placebo multiple doses	multiple doses, daily for 14 days, oral suspension, matching placebo

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-04-01
• Completion: 2016-05-01
• First posted: 2016-01-25
• Last updated: 2016-07-29

Locations

1 site across 1 country: Belgium