NCT02179502

First-in-Human Single and Multiple Dose of GLPG1690

Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1690 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 GLPG1690 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 given to healthy male 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 GLPG1690 present in the blood and urine (pharmacokinetics) as well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics) will be characterized compared to placebo. The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of a liquid dosage formulation of GLPG1690. Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690 will be explored.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG1690 single ascending doses	Single dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg
DRUG	Placebo single ascending doses	Single dose, oral suspension or solid formulation matching placebo
DRUG	GLPG1690, multiple ascending doses, oral suspension	Multiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg
DRUG	Placebo, multiple ascending doses, oral suspension	Multiple doses, daily for 14 days, oral suspension matching placebo

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2014-07-01
• Last updated: 2015-09-22

Locations

1 site across 1 country: Belgium