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First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187

NCT ID: NCT00928343

Last Updated: 2010-01-15

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-12-31

Brief Summary

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The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) subcutaneous and single oral dose of GLPG0187 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous and 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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GLPG0187

Single dose

Group Type EXPERIMENTAL

GLPG0187

Intervention Type DRUG

Single ascending subcutaneous doses (subcutaneous solution), and single oral dose (oral solution)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching subcutaneous or oral placebo

Interventions

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GLPG0187

Single ascending subcutaneous doses (subcutaneous solution), and single oral dose (oral solution)

Intervention Type DRUG

Placebo

Matching subcutaneous or oral placebo

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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Giocondo Lorenzon, 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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GLPG0187-CL-101

Identifier Type: -

Identifier Source: org_study_id

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