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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989703
• Other study ID #: GLPG0259-CL-102
• Status: Completed
• Phase: Phase 1
• First received: October 2, 2009
• Last updated: February 17, 2012
• Start date: September 2009
• Est. completion date: January 2010

Study information

• Verified date: February 2012
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• placebo
oral solution, daily for 14 days
• GLPG0259
oral solution
• Methotrexate
7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14

Locations

Country	Name	City	State
Belgium	SGS Stuivenberg	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of oral multiple ascending doses		up to 10 days postdose	No
Secondary	Pharmacokinetics of multiple oral doses		up to 10 days postdose	No
Secondary	To explore the pharmacokinetic interaction between GLPG0259 and methotrexate (MTX).		up to 10 days postdose	No
Secondary	To explore biomarkers of GLPG0259 activity after multiple oral administrations.		up to 24 hours postdose	No