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

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ClinicalTrials.gov Identifier: NCT00989703
Recruitment Status : Completed
First Posted : October 5, 2009
Last Update Posted : February 20, 2012
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: placebo Drug: GLPG0259 Drug: Methotrexate Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date : September 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
GLPG0259 25/50/75 mg/day 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®
Placebo Comparator: 2
placebo for 14 days
Drug: placebo
oral solution, daily for 14 days
Drug: Methotrexate
7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14
Other Name: Ledertrexate®



Primary Outcome Measures :
  1. Safety and tolerability of oral multiple ascending doses [ Time Frame: up to 10 days postdose ]

Secondary Outcome Measures :
  1. Pharmacokinetics of multiple oral doses [ Time Frame: up to 10 days postdose ]
  2. To explore the pharmacokinetic interaction between GLPG0259 and methotrexate (MTX). [ Time Frame: up to 10 days postdose ]
  3. To explore biomarkers of GLPG0259 activity after multiple oral administrations. [ Time Frame: up to 24 hours postdose ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989703


Locations
Belgium
SGS Stuivenberg
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Johan Beetens, PharmD, PhD Galapagos NV
Principal Investigator: Lien Gheyle, MD SGS Stuivenberg

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT00989703     History of Changes
Other Study ID Numbers: GLPG0259-CL-102
First Posted: October 5, 2009    Key Record Dates
Last Update Posted: February 20, 2012
Last Verified: February 2012

Keywords provided by Galapagos NV:
Safety
Tolerability
Pharmacokinetics

Additional relevant MeSH terms:
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors