Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects

NCT ID: NCT01665924

Last Updated: 2013-03-28

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-10-31

Brief Summary

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The purpose of the study is to evaluate the amount of compound present in the blood (pharmacokinetics) after single and of multiple doses of GLPG0634 in elderly healthy subjects.

During the course of the study, the effect of aging on the pharmacokinetics as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be assessed and the safety of multiple oral doses of GLPG0634 in elderly healthy subjects will be characterized.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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40-50 years old

GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 40 and 50 years old

Group Type EXPERIMENTAL

GLPG0634 100mg capsule once a day for 10 days

Intervention Type DRUG

65-74 years old

GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 65 and 74 years old

Group Type EXPERIMENTAL

GLPG0634 100mg capsule once a day for 10 days

Intervention Type DRUG

75 years and older

GLPG0634 100mg capsule once a day for 10 days in healthy subjects of 75 years and older

Group Type EXPERIMENTAL

GLPG0634 100mg capsule once a day for 10 days

Intervention Type DRUG

Interventions

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GLPG0634 100mg capsule once a day for 10 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female, age 40 years and older
* BMI between 18-30 kg/m2

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

Eligible Sex

ALL

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

Magdalena Petkova, MD

Role: PRINCIPAL_INVESTIGATOR

SGS LSS Clinical Pharmacology Unit Antwerp

Locations

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SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Antwerp, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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GLPG0634-CL-104

Identifier Type: -

Identifier Source: org_study_id

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