NCT03214614

A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2451 in Healthy Male Subjects

Assessment of Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses of GLPG2451 and of the Combination of GLPG2451 and GLPG2222 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The study is a Phase I, randomized, double-blind, placebo-controlled study evaluating multiple ascending oral doses of GLPG2451 and the combination of GLPG2451 and GLPG2222 given for 14 days in healthy male subjects. The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG2451 given to healthy male subjects compared to placebo, as well as of multiple oral doses of the combination of GLPG2451/GLPG2222 compared to placebo.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG2451 multiple dose	GLPG2451 oral suspension, multiple ascending doses, daily for 14 days
DRUG	Placebo multiple dose	Placebo, oral suspension, daily for 14 days
DRUG	GLPG2451/GLPG2222 multiple dose	GLPG2451 oral suspension and GLPG2222 oral suspension, multiple doses, daily for 14 days
DRUG	Combined Placebo multiple dose	Combined Placebo, oral suspension, daily for 14 days

Timeline

• Start date: 2016-11-14
• Primary completion: 2017-08-25
• Completion: 2017-08-25
• First posted: 2017-07-11
• Last updated: 2017-09-13

Locations

1 site across 1 country: Belgium