MD Ezetimibe Cyclosporine Interaction (0653-057)

Organon and Co13 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cholesterol

Interventions

ezetimibeDRUG

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

Comparator: cyclosporineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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