NCT01820806

Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects

Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects Following a Single Oral Administration of [14C] GLPG0634

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This will be a study in 6 healthy male subjects, each receiving a single oral dose of 100 mg \[14C\]-radiolabeled GLPG0634. The study aims to establish the elimination pathways of GLPG0634 and their relative significance and to assess the metabolite profile of GLPG0634 in plasma and in excreta. Furthermore, the pharmacokinetics (PK) of the main metabolites in plasma relative to GLPG0634 will be evaluated. This study will also provide safety and tolerability information for GLPG0634.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	100 mg dose of [14C] GLPG0634	Subjects will be dosed with a single oral 100 mg dose of \[14C\] GLPG0634 on one occasion

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2013-03-29
• Last updated: 2013-05-07

Locations

1 site across 1 country: United Kingdom