MD Ezetimibe Cyclosporine Interaction (0653-057)

NCT ID: NCT00653276

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2004-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A

Treatment A: subjects will be given a single oral dose of cyclosporine 100 mg capsules on Day 1.

Group Type ACTIVE_COMPARATOR

Comparator: cyclosporine

Intervention Type DRUG

single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.

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.

Group Type ACTIVE_COMPARATOR

ezetimibe

Intervention Type DRUG

ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.

Comparator: cyclosporine

Intervention Type DRUG

single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.

Interventions

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ezetimibe

ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.

Intervention Type DRUG

Comparator: cyclosporine

single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.

Intervention Type DRUG

Other Intervention Names

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MK0653 Zetia®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Schering-Plough

INDUSTRY

Sponsor Role collaborator

Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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. doi: 10.1177/0091270005284851.

Reference Type BACKGROUND
PMID: 16490808 (View on PubMed)

Other Identifiers

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MK0653-057

Identifier Type: -

Identifier Source: secondary_id

2008_520

Identifier Type: -

Identifier Source: secondary_id

0653-057

Identifier Type: -

Identifier Source: org_study_id

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