MD Ezetimibe Cyclosporine Interaction

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00653276
First received: April 1, 2008
Last updated: April 13, 2009
Last verified: April 2009
  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 Sharp & Dohme Corp.:

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:
  • MK0653
  • Zetia®
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653276

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Schering-Plough
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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 April 17, 2014