NCT02325037

First-in-Human Single and Multiple Dose of GLPG1837

Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG1837 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• 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 GLPG1837 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy subjects daily for 14 days compared to placebo, will be evaluated. Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1837 and its metabolite present in the blood and urine (pharmacokinetics) will be characterized. The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be evaluated. The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will be explored as well.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG1837 single ascending doses	Single dose, oral suspension
DRUG	Placebo single dose	Single dose, oral suspension matching placebo
DRUG	GLPG1837 multiple ascending doses	Multiple doses, daily for 14 days, oral suspension
DRUG	Placebo multiple doses	Multiple doses, daily for 14 days, oral suspension, matching placebo

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-12-24
• Last updated: 2015-09-09

Locations

1 site across 1 country: Belgium