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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00989703

Enrollment

Registered

2009-10-05

Start date

2009-09-30

Completion date

2010-01-31

Last updated

2012-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, Tolerability, Pharmacokinetics

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.

Interventions

DRUGGLPG0259

oral solution

DRUGMethotrexate

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

DRUGplacebo

oral solution, daily for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of oral multiple ascending doses	up to 10 days postdose

Secondary

Measure	Time frame
To explore biomarkers of GLPG0259 activity after multiple oral administrations.	up to 24 hours postdose
To explore the pharmacokinetic interaction between GLPG0259 and methotrexate (MTX).	up to 10 days postdose
Pharmacokinetics of multiple oral doses	up to 10 days postdose

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026