NCT03128606

A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG3067 in Healthy Subjects.

Assessment of Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3067, the Combination of GLPG3067 and GLPG2222, and the Combination of GLPG3067, GLPG2222 and GLPG2737 in Healthy Female Subjects, Including a Relative Bioavailability and Food Effect Part for Single Dose of GLPG3067.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled, single center study, evaluating single and multiple ascending oral doses of GLPG3067 and the combination of GLPG3067 and GLPG2222 and the combination of GLPG3067,GLPG2222 and GLPG2737 given for 14 days in healthy women of non-childbearing potential. The purpose of the study is to evaluate the safety and tolerability of single ascending oral doses and multiple ascending oral doses of GLPG3067 given to healthy women of non-childbearing potential compared to placebo, as well as of multiple oral doses of the combination of GLPG3067/GLPG2222 compared to matching placebo for each compound and multiple oral doses of the combination of GLPG3067/GLPG2222/GLPG2737 compared to matching placebo for each compound.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG3067 single dose	GLPG3067 oral suspension, single ascending doses, daily
DRUG	Placebo single dose	Placebo, oral suspension, daily
DRUG	GLPG3067 multiple dose	GLPG3067 oral suspension, multiple ascending doses, daily for 14 days
DRUG	Placebo multiple dose	Placebo, oral suspension, daily for 14 days
DRUG	GLPG3067 oral suspension	GLPG3067 oral suspension, single dose, daily
DRUG	GLPG3067 oral tablet	GLPG3067 oral tablet, single dose, daily
DRUG	GLPG3067/GLPG2222 multiple dose	GLPG3067 oral suspension and GLPG2222 oral tablet, multiple doses, daily for 14 days
DRUG	GLPG3067/GLPG2222 Placebo multiple dose	GLPG3067 matching placebo oral suspension and GLPG2222 matching placebo oral tablet, multiple doses, daily for 14 days
DRUG	GLPG3067/GLPG2222/GLPG2737 multiple dose	GLPG3067 oral tablet, GLPG2222 oral tablet and GLPG2737 oral capsule, multiple doses, daily for 14 days
DRUG	GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose	GLPG3067 matching placebo oral tablet, GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule, multiple doses, daily for 14 days

Timeline

• Start date: 2017-03-28
• Primary completion: 2018-02-20
• Completion: 2018-02-20
• First posted: 2017-04-25
• Last updated: 2018-04-10

Locations

1 site across 1 country: Belgium