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
  Purpose

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 Intervention Phase
Healthy
Drug: placebo
Drug: GLPG0259
Drug: Methotrexate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • Safety and tolerability of oral multiple ascending doses [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: September 2009
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT00989703     History of Changes
Other Study ID Numbers: GLPG0259-CL-102
Study First Received: October 2, 2009
Last Updated: February 17, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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
Pharmacologic Actions
Therapeutic Uses
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

ClinicalTrials.gov processed this record on August 27, 2014