Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects

NCT ID: NCT01721980

Last Updated: 2013-02-12

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-02-28

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability after multiple ascending oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo.

Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood and stool samples (pharmacodynamics) will be characterized compared to placebo.

Also, the effect of the compound on glucose tolerance will be explored as well as the potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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50 mg GLPG0974 or placebo

50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days

Group Type OTHER

GLPG0974

Intervention Type DRUG

Placebo

Intervention Type DRUG

100 mg GLPG0974 or placebo

100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days

Group Type OTHER

GLPG0974

Intervention Type DRUG

Placebo

Intervention Type DRUG

200 mg GLPG0974 or placebo

200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days

Group Type OTHER

GLPG0974

Intervention Type DRUG

Placebo

Intervention Type DRUG

400 mg GLPG0974 or placebo

400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days

Group Type OTHER

GLPG0974

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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GLPG0974

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male, age 18-50 years
* 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

18 Years

Maximum Eligible Age

50 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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SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Antwerp, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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GLPG0974-CL-102

Identifier Type: -

Identifier Source: org_study_id

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