NCT03899909

A Study to Evaluate the Effects of a Single and Multiple Oral Doses of GLPG3121 in Adult, Healthy, Male Subjects

A First-in-human, Randomized, Double-blind, Placebo-controlled, Single Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG3121 for 13 Days in Adult, Healthy, Male Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (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, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3121 after oral single ascending doses (SAD) of GLPG3121 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3121 (part 2) in healthy male subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG3121 SAD	GLPG3121 oral suspension, single ascending doses
DRUG	Placebo SAD	Placebo oral suspension
DRUG	GLPG3121 MAD	GLPG3121 oral suspension, multiple ascending doses, daily for 13 days
DRUG	Placebo MAD	Placebo oral suspension, daily for 13 days

Timeline

• Start date: 2019-03-29
• Primary completion: 2019-06-03
• Completion: 2019-06-03
• First posted: 2019-04-02
• Last updated: 2019-07-05

Locations

1 site across 1 country: Belgium