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

NCT01820806 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2013-05-07

No results posted yet for this study

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

DRUG

100 mg dose of [14C] GLPG0634

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

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Frédéric - Vanhoutte, MD · Galapagos NV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01820806 on ClinicalTrials.gov