Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects
NCT ID: NCT01820806
Last Updated: 2013-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2013-03-31
2013-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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[14C] GLPG0634
Subjects will be dosed with a single oral 100 mg dose of \[14C\] GLPG0634 on one occasion
100 mg dose of [14C] GLPG0634
Subjects will be dosed with a single oral 100 mg dose of \[14C\] GLPG0634 on one occasion
Interventions
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100 mg dose of [14C] GLPG0634
Subjects will be dosed with a single oral 100 mg dose of \[14C\] GLPG0634 on one occasion
Eligibility Criteria
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Inclusion Criteria
* within BMI range 18 to 30 kg/m2, inclusive
Exclusion Criteria
* Drug or alcohol abuse
* Smoking
40 Years
65 Years
MALE
Yes
Sponsors
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Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Frédéric - Vanhoutte, MD
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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Quotient Clinical
Nottingham, , United Kingdom
Countries
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Other Identifiers
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GLPG0634-CL-105
Identifier Type: -
Identifier Source: org_study_id
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