GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy Subjects
NCT ID: NCT00989703
Last Updated: 2012-02-20
Study Results
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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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2009-09-30
2010-01-31
Brief Summary
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Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after multiple increasing oral doses, and potential drug-drug interaction with single dose methotrexate will be assessed.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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1
GLPG0259 25/50/75 mg/day for 14 days
GLPG0259
oral solution
Methotrexate
7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14
2
placebo for 14 days
placebo
oral solution, daily for 14 days
Methotrexate
7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14
Interventions
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placebo
oral solution, daily for 14 days
GLPG0259
oral solution
Methotrexate
7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI between 18-30 kg/m², inclusive.
Exclusion Criteria
* smoking
* drug or alcohol abuse
18 Years
50 Years
MALE
Yes
Sponsors
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Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Johan Beetens, PharmD, PhD
Role: STUDY_DIRECTOR
Galapagos NV
Lien Gheyle, MD
Role: PRINCIPAL_INVESTIGATOR
SGS Stuivenberg
Locations
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SGS Stuivenberg
Antwerp, , Belgium
Countries
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Other Identifiers
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GLPG0259-CL-102
Identifier Type: -
Identifier Source: org_study_id
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