Multiple Ascending Dose Study of GLPG0634 in Japanese and Caucasian Healthy Subjects

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

2014-06-30

Study Completion Date

2014-09-30

Brief Summary

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The purpose of this multiple ascending dose study is to characterize the safety, tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in Japanese healthy subjects.

Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of once daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese vs Caucasian healthy subjects.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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GLPG0634 in Japanese subjects

Per panel, 6 Japanese healthy subjects will receive one of the three doses (50 mg, 100 mg or 200 mg) of GLPG0634 as tablets once daily for 10 days

Group Type EXPERIMENTAL

GLPG0634 50 mg

Intervention Type DRUG

2 tablets of 25 mg GLPG0634 once daily for 10 days

GLPG0634 100 mg

Intervention Type DRUG

1 tablet of 100 mg GLPG0634 once daily for 10 days

GLPG0634 200 mg

Intervention Type DRUG

2 tablets of 100 mg GLPG0634 once daily for 10 days

Placebo in Japanese healthy subjects

Per panel, 2 or 4 (last panel only) Japanese healthy subjects will receive placebo as tablets once daily for 10 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 or 2 matching placebo tablets once daily for 10 days

GLPG0634 in Caucasian subjects

In the last panel, 6 Caucasian healthy subjects will receive one dose of GLPG0634 (200 mg) as tablets once daily for 10 days

Group Type EXPERIMENTAL

GLPG0634 200 mg

Intervention Type DRUG

2 tablets of 100 mg GLPG0634 once daily for 10 days

Placebo in Caucasian healthy subjects

In the last panel, 4 Caucasian healthy subjects will receive receive placebo as tablets once daily for 10 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 or 2 matching placebo tablets once daily for 10 days

Interventions

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GLPG0634 50 mg

2 tablets of 25 mg GLPG0634 once daily for 10 days

Intervention Type DRUG

GLPG0634 100 mg

1 tablet of 100 mg GLPG0634 once daily for 10 days

Intervention Type DRUG

GLPG0634 200 mg

2 tablets of 100 mg GLPG0634 once daily for 10 days

Intervention Type DRUG

Placebo

1 or 2 matching placebo tablets once daily for 10 days

Intervention Type DRUG

Other Intervention Names

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50 mg GLPG0634 as tablets 100 mg GLPG0634 as tablets 200 mg GLPG0634 as tablets Placebo as matching tablets

Eligibility Criteria

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Inclusion Criteria

* Male or female Japanese or Caucasian subjects between 20-65 years of age (included)
* Subjects must have a body mass index between 18-28 kg/m² (included)
* Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile

Exclusion Criteria

* A subject with a known hypersensitivity to ingredients of the study drug or a significant allergic reaction to any drug
* Concurrent participation or participation within 3 months prior to the initial study drug administration in a drug/device or biologic investigational research study
* A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
* Subject expresses current desire to have (more) children
* Female subject is less than 6 months post-partum, post-abortion or post lactation prior to study drug administration or is pregnant or breastfeeding

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes