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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 |
|
Safety Tolerability Pharmacokinetics |
|
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 |