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GLPG0778: Multiple Ascending Oral Doses, Pharmacokinetic, Safety, and Pharmacodynamic Study

NCT ID: NCT01336244

Last Updated: 2011-10-18

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-09-30

Brief Summary

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The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.

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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GLPG0778 ascending doses

Multiple ascending doses for 13 days, ranging from 50 mg twice daily upto a maximum to be determined during escalation.

Group Type EXPERIMENTAL

GLPG0778

Intervention Type DRUG

capsules containing 50 or 100 mg of GLPG0778

Placebo

Twice daily for 13 days, matching the scheme of the multiple ascending dose.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

Interventions

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GLPG0778

capsules containing 50 or 100 mg of GLPG0778

Intervention Type DRUG

placebo

multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy male, age 18-50 years
* body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion Criteria

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse
* hypersensitivity to any of the test substances
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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Gerben van 't Klooster, PhD

Role: STUDY_DIRECTOR

Galapagos NV

Lien Gheyle, 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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2011-000892-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG0778-CL-102

Identifier Type: -

Identifier Source: org_study_id