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First-in-Human Exploratory Single Ascending Dose of GLPG0974

NCT ID: NCT01496937

Last Updated: 2012-04-19

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

2011-12-31

Study Completion Date

2012-02-29

Brief Summary

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The purpose of this exploratory first-in-human study is to evaluate the amount of GLPG0974 present in the blood (pharmacokinetics) after single oral doses of GLPG0974 given to healthy subjects.

Furthermore, during the course of the study, safety and tolerability as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized compared to placebo.

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GLPG0974 oral solution

GLPG0974 oral solution

Group Type EXPERIMENTAL

GLPG0974

Intervention Type DRUG

Placebo oral solution

Placebo oral solution

Group Type PLACEBO_COMPARATOR

GLPG0974

Intervention Type DRUG

Interventions

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GLPG0974

Intervention Type DRUG

GLPG0974

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

Wouter Haazen, MD

Role: PRINCIPAL_INVESTIGATOR

SGS Stuivenberg

Locations

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SGS Stuivenberg

Antwerp, Antwerp, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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GLPG0974-CL-101

Identifier Type: -

Identifier Source: org_study_id

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