NCT02612246

First-in-Human Single and Multiple Dose of GLPG1972

Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1972 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (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 GLPG1972 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1972 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 GLPG1972 present in the blood and urine (pharmacokinetics) will be characterized. The effect of food on the pharmacokinetics of GLPG1972 will also be evaluated. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG1972 will be explored as well. During the course of the study after multiple oral dose administrations, the effect of GLPG1972 on biomarkers present in the blood (pharmacodynamics) will be characterized.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG1972 single ascending doses	single dose, oral solution
DRUG	Placebo single dose	single dose, oral solution, matching placebo
DRUG	GLPG1972 multiple ascending doses	multiple doses, daily for 14 days, oral solution
DRUG	Placebo multiple doses	multiple doses, daily for 14 days, oral solution

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-04-01
• Completion: 2016-07-01
• First posted: 2015-11-23
• Last updated: 2016-07-29

Locations

1 site across 1 country: Belgium