NCT02788721

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled study evaluating single and multiple ascending oral doses of GLPG2451 and combined multiple doses of GLPG2451 and GLPG2222 in healthy female subjects. The purpose of the study is to evaluate safety and tolerability after single ascending oral doses and of multiple doses of GLPG2451 given to healthy female subjects compared to placebo as well as of multiple doses of the combination of GLPG2451/GLPG2222 compared to GLPG2451/placebo.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG2451 single dose	GLPG2451 oral suspension, single ascending doses, daily
DRUG	Placebo	Placebo, oral suspension, daily

Timeline

• Start date: 2016-04-14
• Primary completion: 2017-04-27
• Completion: 2017-04-27
• First posted: 2016-06-02
• Last updated: 2017-07-12

Locations

1 site across 1 country: Belgium