Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food
NCT ID: NCT02143856
Last Updated: 2014-07-22
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
12 participants
INTERVENTIONAL
2014-05-31
2014-07-31
Brief Summary
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Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule formulation under fasted and fed conditions 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
CROSSOVER
TREATMENT
NONE
Study Groups
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100 mg GLPG1205 fasted
Single dose of 100 mg GLPG1205 as two capsules of 50 mg after an overnight fast
100 mg GLPG1205
A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg
100 mg GLPG1205 fed
Single dose of 100 mg GLPG1205 as two capsules of 50 mg exactly 30 minutes after the start of a high-fat, high-calorie breakfast
100 mg GLPG1205
A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg
Interventions
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100 mg GLPG1205
A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg
Eligibility Criteria
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Inclusion Criteria
* BMI between 18-30 kg/m2
Exclusion Criteria
* Drug or alcohol abuse
* Smoking
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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Frédéric Vanhoutte, MD
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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SGS LSS Clinical Pharmacology Unit Antwerp
Antwerp, Antwerp, Belgium
Countries
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Other Identifiers
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2013-004771-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GLPG1205-CL-102
Identifier Type: -
Identifier Source: org_study_id
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