GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy Subjects
This study has been completed.
Sponsor:
Galapagos NV
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
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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 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 May 23, 2013