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First-in-Human Single Ascending and Multiple Dose of GLPG0259

NCT ID: NCT00905138

Last Updated: 2012-02-20

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

2009-03-31

Study Completion Date

2009-06-30

Brief Summary

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The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0259 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

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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

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

single ascending doses

Group Type EXPERIMENTAL

GLPG0259

Intervention Type DRUG

single ascending doses, oral solution

2

single dose placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

single dose, oral solution

3

multiple dose, 5 days, oral solution

Group Type EXPERIMENTAL

GLPG0259

Intervention Type DRUG

multiple dose, oral solution, 5 days

4

multiple dose, 5 days, oral solution

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral solution, 5 days

Interventions

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GLPG0259

single ascending doses, oral solution

Intervention Type DRUG

placebo

single dose, oral solution

Intervention Type DRUG

GLPG0259

multiple dose, oral solution, 5 days

Intervention Type DRUG

placebo

oral solution, 5 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy male, age 18-50 years
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse
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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Galapagos NV

Principal Investigators

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Johan Beetens, PharmD, PhD

Role: STUDY_DIRECTOR

Galapagos NV

Eva Vets, MD

Role: PRINCIPAL_INVESTIGATOR

SGS Stuivenberg

Locations

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SGS Stuivenberg

Antwerp, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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GLPG0259-CL-101

Identifier Type: -

Identifier Source: org_study_id

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