NCT01322451CompletedPhase 1
A Randomized, Open Label, 2-way Crossover Study to Compare the Oral Bioavailability of 2 Solid Dose Formulations of GLPG0259 After Single-dose Intake in Healthy Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Galapagos NV
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Bioavailability of two solid dosage formulations of GLPG0259
Study Overview
Brief Summary
The purpose of the study is to evaluate the relative bioavailability of two solid oral formulations of GLPG0259 administered after a meal.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy male, age 18-50 years
- •BMI between 18-30 kg/m², inclusive.
Exclusion Criteria
- •significantly abnormal platelet function or coagulopathy
- •drug or alcohol abuse
Arms & Interventions
Single oral dose, single capsule
Experimental
Intervention: GLPG0259 free base (Drug)
Single oral dose, two capsules
Experimental
Intervention: GLPG0259 fumarate (Drug)
Outcomes
Primary Outcomes
Bioavailability of two solid dosage formulations of GLPG0259
Time Frame: up to 96 hours postdose
Secondary Outcomes
- Safety and tolerability of GLPG0259(up to 96 hours postdose)
Investigators
Study Sites (1)
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