MD Ezetimibe Cyclosporine Interaction
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: January 2004
Intervention(s) in this Clinical Trial
- Drug: ezetimibe
- ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.
- Drug: Comparator: cyclosporine
- single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: Treatment A
- Treatment A: subjects will be given a single oral dose of cyclosporine 100 mg capsules on Day 1.
- 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.
Outcome Measures for this Clinical Trial
Primary 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.
Safety Issue?: No
- Time Frame: Blood sampling will be conducted for 48 hours starting with the first cyclosporine dosing.
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
Bergman AJ, Burke J, Larson P, Johnson-Levonas AO, Reyderman L, Statkevich P, Kosoglou T, Greenberg HE, Kraft WK, Frick G, Murphy G, Gottesdiener K, Paolini JF. Effects of ezetimibe on cyclosporine pharmacokinetics in healthy subjects. J Clin Pharmacol. 2006 Mar;46(3):321-7.
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00653276
Study ID Number: 2008_520
ClinicalTrials.gov Identifier: NCT00653276
Health Authority: United States: Food and Drug Administration
MedWatch - FDA maintained medical product safety Information
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00653276
