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MD Ezetimibe Cyclosporine Interaction (0653-057)

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00653276
First received: April 1, 2008
Last updated: August 11, 2014
Last verified: August 2014
  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
Study Completion Date: January 2004
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00653276     History of Changes
Other Study ID Numbers: 0653-057, MK0653-057, 2008_520
Study First Received: April 1, 2008
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cyclosporine
Cyclosporins
Ezetimibe
Anti-Infective Agents
Anticholesteremic Agents
Antifungal Agents
Antimetabolites
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Hypolipidemic Agents
Immunologic Factors
Immunosuppressive Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014