First-in-Human Single Ascending and Multiple Dose of GLPG0634
NCT ID: NCT01179581
Last Updated: 2011-03-24
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
48 participants
INTERVENTIONAL
2010-08-31
2011-03-31
Brief Summary
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Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.
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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
single ascending doses
GLPG0634
single ascending doses, oral solution (1 to 10 mg/dose) and capsules (10 to 200 mg/dose)
2
single dose placebo
placebo
single dose, oral solution or capsule (matching corresponding study medication)
3
multiple dose, 10 days, capsules (dosing depends on outcome of single-dose part; can be once or twice daily).
GLPG0634
multiple dose, capsule, 10 days
4
multiple dose, capsules, 10 days; scheme to match that of Study Arm 3.
placebo
multiple dose, capsule, 10 days
Interventions
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GLPG0634
single ascending doses, oral solution (1 to 10 mg/dose) and capsules (10 to 200 mg/dose)
placebo
single dose, oral solution or capsule (matching corresponding study medication)
GLPG0634
multiple dose, capsule, 10 days
placebo
multiple dose, capsule, 10 days
Eligibility Criteria
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Inclusion Criteria
* body mass index (BMI) between 18-30 kg/m², inclusive.
Exclusion Criteria
* smoking
* drug or alcohol abuse
40 Years
60 Years
MALE
Yes
Sponsors
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Galapagos NV
INDUSTRY
Responsible Party
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Galapagos NV
Principal Investigators
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Gerben van 't Klooster, PhD
Role: STUDY_DIRECTOR
Galapagos NV
Eva Vets, MD
Role: PRINCIPAL_INVESTIGATOR
SGS Stuivenberg
Locations
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SGS Stuivenberg
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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2010-018440-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GLPG0634-CL-101
Identifier Type: -
Identifier Source: org_study_id
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