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

Sponsor:	Galapagos NV
Information provided by:	Galapagos NV
ClinicalTrials.gov Identifier:	NCT00989703

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 I

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:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Methotrexate

U.S. FDA Resources

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

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:	Senior Vice President Development, Galapagos NV
ClinicalTrials.gov Identifier:	NCT00989703 History of Changes
Other Study ID Numbers:	GLPG0259-CL-102
Study First Received:	October 2, 2009
Last Updated:	January 14, 2010
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 February 09, 2012