MD Ezetimibe Cyclosporine Interaction (0653-057)

February 7, 2022 updated by: Organon and Co

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Comparator: cyclosporine
single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.
Drug: ezetimibe
ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.
Other Names:
  • Zetia®
  • MK0653

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Blood sampling will be conducted for 48 hours starting with the first cyclosporine dosing.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Collaborators

Schering-Plough

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 4, 2008

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0653-057
  • MK0653-057
  • 2008_520

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis Link

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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