Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of GLPG0634 in Healthy Subjects
NCT ID: NCT01419990
Last Updated: 2012-08-15
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
16 participants
INTERVENTIONAL
2011-08-31
2011-10-31
Brief Summary
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During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GLPG0634 capsules
GLPG0634
GLPG0634 300 mg oral capsules, qd, 10 days
GLPG0634
GLPG0634 450 mg oral capsules, qd, 10 days
Placebo capsules
Placebo
Placebo oral capsules, qd, 10 days
Interventions
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GLPG0634
GLPG0634 300 mg oral capsules, qd, 10 days
GLPG0634
GLPG0634 450 mg oral capsules, qd, 10 days
Placebo
Placebo oral capsules, qd, 10 days
Eligibility Criteria
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Inclusion Criteria
* BMI between 18-30 kg/m2
Exclusion Criteria
* Drug or alcohol abuse
* Smoking
40 Years
60 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
Lien Gheyle, MD
Role: PRINCIPAL_INVESTIGATOR
SGS Stuivenberg
Locations
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SGS Stuivenberg
Antwerp, Antwerp, Belgium
Countries
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References
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Namour F, Diderichsen PM, Cox E, Vayssiere B, Van der Aa A, Tasset C, Van't Klooster G. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of Filgotinib (GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection. Clin Pharmacokinet. 2015 Aug;54(8):859-74. doi: 10.1007/s40262-015-0240-z.
Other Identifiers
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GLPG0634-CL-102
Identifier Type: -
Identifier Source: org_study_id