MD Ezetimibe Cyclosporine Interaction
This study has been completed.
Sponsor:
Merck
Collaborator:
Schering-Plough
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00653276
First received: April 1, 2008
Last updated: April 13, 2009
Last verified: April 2009
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Purpose
Study to determine the effect of multiple oral doses of ezetimibe on the pharmacokinetics of a single oral dose cyclosporine in young healthy males and females.
| Condition | Intervention | Phase |
|---|---|---|
|
Cholesterol |
Drug: ezetimibe Drug: Comparator: cyclosporine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, 2-Period, Crossover Study to Determine the Effect of Multiple Oral Doses of Ezetimibe 20 mg on the Pharmacokinetics of a Single Oral Dose of Cyclosporine in Young, Healthy, Normal, Male and Female Subjects |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- To evaluate the safety and tolerability of cyclosporine coadministered with ezetimibe vs. cyclosporine administered alone. [ Time Frame: Blood sampling will be conducted for 48 hours starting with the first cyclosporine dosing. ] [ Designated as safety issue: No ]
| Enrollment: | 13 |
| Study Start Date: | November 2003 |
| Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Treatment A
Treatment A: subjects will be given a single oral dose of cyclosporine 100 mg capsules on Day 1.
|
Drug: Comparator: cyclosporine
single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.
|
|
Active Comparator: Treatment B
Treatment B: subjects will receive single oral daily doses of ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through 6, followed by coadministration of a single oral dose of ezetimibe 20 mg (2 x 10 mg tablets) and cyclosporine 100 mg capsule on Day 7.
|
Drug: ezetimibe
ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.
Other Names:
Drug: Comparator: cyclosporine
single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subject is male or female between 18 to 45 years of age
- Subject is judged to be in good health on the basis of history, physical examination, and routine laboratory data
Exclusion Criteria:
- Premenopausal women who are currently pregnant or who are currently nursing
- Subjects with drug or substance abuse, poor mental function, history of major gastrointestinal abnormalities (stomach issues), or high cholesterol
- Subject that has donated blood or has participated in another clinical trial within the last four weeks
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| ClinicalTrials.gov Identifier: | NCT00653276 History of Changes |
| Other Study ID Numbers: | 2008_520, MK0653-057 |
| Study First Received: | April 1, 2008 |
| Last Updated: | April 13, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cyclosporins Cyclosporine Ezetimibe Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents |
ClinicalTrials.gov processed this record on May 22, 2013