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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG0259; Drug: placebo; Drug: Methotrexate

• Registration Number: NCT00989703
• Lead Sponsor: Galapagos NV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-02
• Study First Posted: 2009-10-05
• Primary Completion: 2009-11
• Study Completion: 2010-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-17
• Last Update Posted: 2012-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• healthy male, age 18-50 years
• BMI between 18-30 kg/m², inclusive.

Exclusion Criteria

• significantly abnormal platelet function or coagulopathy
• smoking
• drug or alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	GLPG0259	GLPG0259 25/50/75 mg/day for 14 days
2	placebo	placebo for 14 days
1	Methotrexate	GLPG0259 25/50/75 mg/day for 14 days
2	Methotrexate	placebo for 14 days

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of oral multiple ascending doses	up to 10 days postdose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

SGS Stuivenberg; 🇧🇪 Antwerp, Belgium