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

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG0259; Drug: placebo; Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00989703

GLPG0259-CL-102

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

GLPG0259 25/50/75 mg/day for 14 days

Treatment:

Drug: Methotrexate

Drug: GLPG0259

2

Placebo Comparator group

Description:

placebo for 14 days

Treatment:

Drug: Methotrexate

Drug: placebo