NCT01419990CompletedPhase 1
Double-blind Placebo Controlled Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Dosing of GLPG0634 in Healthy Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Galapagos NV
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Safety and tolerability
Study Overview
Brief Summary
The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male, age 40-60 years
- •BMI between 18-30 kg/m2
Exclusion Criteria
- •Any condition that might interfere with the procedures or tests in this study
- •Drug or alcohol abuse
Arms & Interventions
GLPG0634 capsules
Experimental
Intervention: GLPG0634 (Drug)
Placebo capsules
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety and tolerability
Time Frame: From screening up to 10 days after the last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo after multiple oral doses in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
Secondary Outcomes
- Pharmacokinetics (PK) and pharmacodynamics (PD)(From first dose up to 10 days after the last dose)
Investigators
Study Sites (1)
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