NCT01887106

First-in-Human Single and Multiple Dose of GLPG1205

Randomized, Double-blind, Placebo-controlled, Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1205 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 GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 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 GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo. Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG1205 single ascending doses, oral suspension	Single dose, oral suspension at 10 mg/mL or 50 mg/mL, starting dose of 10mg escalating up to 800mg
DRUG	Placebo single ascending doses, oral suspension	Single dose, oral suspension matching placebo
DRUG	GLPG1205, multiple ascending doses, oral suspension	Multiple doses, daily for 14 days, oral suspension at 10 mg/mL or 50 mg/mL, anticipated doses: 100mg to 400mg
DRUG	Placebo, multiple ascending doses, oral suspension	Multiple doses, daily for 14 days, oral suspension matching placebo

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2013-06-26
• Last updated: 2013-10-16

Locations

1 site across 1 country: Belgium