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

Galapagos NV24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

placeboDRUG

oral solution, daily for 14 days

GLPG0259DRUG

oral solution

MethotrexateDRUG

7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

SGS Stuivenberg

Antwerp, Belgium

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

Time frame: up to 10 days postdose

To explore the pharmacokinetic interaction between GLPG0259 and methotrexate (MTX).

Time frame: up to 10 days postdose

To explore biomarkers of GLPG0259 activity after multiple oral administrations.

Time frame: up to 24 hours postdose

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.