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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galapagos NV
ClinicalTrials.gov Identifier:
NCT00989703
First received: October 2, 2009
Last updated: February 17, 2012
Last verified: February 2012

October 2, 2009
February 17, 2012
September 2009
November 2009   (final data collection date for primary outcome measure)
Safety and tolerability of oral multiple ascending doses [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00989703 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics of multiple oral doses [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: No ]
  • To explore the pharmacokinetic interaction between GLPG0259 and methotrexate (MTX). [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: No ]
  • To explore biomarkers of GLPG0259 activity after multiple oral administrations. [ Time Frame: up to 24 hours postdose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Healthy
  • Drug: placebo
    oral solution, daily for 14 days
  • Drug: GLPG0259
    oral solution
  • Drug: Methotrexate
    7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14
    Other Name: Ledertrexate®
  • Experimental: 1
    GLPG0259 25/50/75 mg/day for 14 days
    Interventions:
    • Drug: GLPG0259
    • Drug: Methotrexate
  • Placebo Comparator: 2
    placebo for 14 days
    Interventions:
    • Drug: placebo
    • Drug: Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
January 2010
November 2009   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00989703
GLPG0259-CL-102
No
Galapagos NV
Galapagos NV
Not Provided
Study Director: Johan Beetens, PharmD, PhD Galapagos NV
Principal Investigator: Lien Gheyle, MD SGS Stuivenberg
Galapagos NV
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP