NCT04097938

A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3667

A First-in-human Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3667 in Adult, Healthy, Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in healthy male subjects. In addition, the effect of food (FE) on safety, tolerability, and PK of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label, randomized, crossover design.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG3667 oral suspension	GLPG3667 oral suspension
DRUG	Placebos	Placebo oral suspension
DRUG	GLPG3667 capsules	GLPG3667 capsules

Timeline

• Start date: 2019-09-18
• Primary completion: 2020-03-04
• Completion: 2020-07-06
• First posted: 2019-09-20
• Last updated: 2024-09-19

Locations

1 site across 1 country: Belgium