NCT00989703

GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	placebo	oral solution, daily for 14 days
DRUG	GLPG0259	oral solution
DRUG	Methotrexate	7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-11-01
• Completion: 2010-01-01
• First posted: 2009-10-05
• Last updated: 2012-02-20

Locations

1 site across 1 country: Belgium