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: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

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.

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

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

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on September 05, 2008

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

PhRMA Clinical Study Results Database - web-based repository for clinical study results

Merck: Patient & Caregiver U.S. Product Web Site