NCT04653467

A Study to Evaluate How Well Single and Multiple Doses of GLPG4399 Are Tolerated in Healthy, Adult Subjects

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 GLPG4399 in Adult, Healthy, Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single (part 1) and multiple ascending (part 2) oral doses of GLPG4399, in adult, healthy, male subjects. In addition, the effect of food and the relative bioavailability (rBA) of GLPG4399, will be evaluated (part 3 and 4).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG4399 oral suspension	GLPG4399 for oral administration
DRUG	GLPG4399 capsules	GLPG4399 for oral administration
DRUG	Placebo	Placebo oral suspension

Timeline

• Start date: 2020-11-06
• Primary completion: 2022-01-10
• Completion: 2022-01-10
• First posted: 2020-12-04
• Last updated: 2022-02-01

Locations

1 site across 1 country: Canada