NCT04136327

A Study in Healthy Male Volunteers to Test How the Test Medicine GLPG1972 is Taken up by the Body When Given by Mouth and Into the Vein as an Injection

A Phase 1, Open-label, Single-center Study to Investigate the Pharmacokinetics and Metabolism of GLPG1972 in Healthy Male Subjects Following Single Intravenous [14C]-GLPG1972 Microtracer and Single Oral [14C]-GLPG1972 Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 30 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The sponsor wants to investigate in this study how well the test medicine is taken up by the body when given orally (by mouth) as a tablet and solution, and as a solution for infusion (into a vein). The oral solution and solution for infusion will be radiolabelled. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the test medicine is in the body, what it is broken down into, and how it leaves the body. The sponsor will also look at the safety and tolerability of the test medicine.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG1972 film-coated tablets	single oral dose of GLPG1972
DRUG	[14C]-GLPG1972 solution for infusion	a 15-minute IV infusion \[14C\]-GLPG1972
DRUG	[14C]-GLPG1972 oral solution	single oral dose of \[14C\]-GLPG1972

Timeline

• Start date: 2019-09-13
• Primary completion: 2019-10-21
• Completion: 2019-10-21
• First posted: 2019-10-23
• Last updated: 2019-11-20

Locations

1 site across 1 country: United Kingdom