Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects
NCT ID: NCT01721980
Last Updated: 2013-02-12
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
32 participants
INTERVENTIONAL
2012-10-31
2013-02-28
Brief Summary
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Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood and stool samples (pharmacodynamics) will be characterized compared to placebo.
Also, the effect of the compound on glucose tolerance will be explored as well as the potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.
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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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50 mg GLPG0974 or placebo
50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
GLPG0974
Placebo
100 mg GLPG0974 or placebo
100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days
GLPG0974
Placebo
200 mg GLPG0974 or placebo
200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
GLPG0974
Placebo
400 mg GLPG0974 or placebo
400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
GLPG0974
Placebo
Interventions
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GLPG0974
Placebo
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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GLPG0974-CL-102
Identifier Type: -
Identifier Source: org_study_id
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