NCT00989703
Completed
Phase 1
Double Blind, Placebo Controlled, Dose Ranging and Methotrexate Interaction Study for the Assessment of Safety, Tolerability and Pharmacokinetics (PK) of Multiple Oral Doses of GLPG0259 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- GLPG0259
- Conditions
- Healthy
- Sponsor
- Galapagos NV
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of oral multiple ascending doses
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of the study is to evaluate the safety and tolerability of multiple increasing oral doses of GLPG0259 compared to placebo.
Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after multiple increasing oral doses, and potential drug-drug interaction with single dose methotrexate will be assessed.
Investigators
Eligibility Criteria
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
1
GLPG0259 25/50/75 mg/day for 14 days
Intervention: GLPG0259
1
GLPG0259 25/50/75 mg/day for 14 days
Intervention: Methotrexate
2
placebo for 14 days
Intervention: placebo
2
placebo for 14 days
Intervention: Methotrexate
Outcomes
Primary Outcomes
Safety and tolerability of oral multiple ascending doses
Time Frame: up to 10 days postdose
Secondary Outcomes
- Pharmacokinetics of multiple oral doses(up to 10 days postdose)
- To explore the pharmacokinetic interaction between GLPG0259 and methotrexate (MTX).(up to 10 days postdose)
- To explore biomarkers of GLPG0259 activity after multiple oral administrations.(up to 24 hours postdose)
Study Sites (1)
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