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

NCT ID: NCT01820806

Last Updated: 2013-05-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

100 mg dose of [14C] GLPG0634

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male, between 40 and 65 years of age, inclusive
* within BMI range 18 to 30 kg/m2, inclusive

Exclusion Criteria

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Galapagos NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric - Vanhoutte, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

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Quotient Clinical

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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GLPG0634-CL-105

Identifier Type: -

Identifier Source: org_study_id

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