MD Ezetimibe Cyclosporine Interaction (0653-057)

Organon

Status and phase: Completed; Phase 1

Conditions: Cholesterol

Treatments: Drug: Comparator: cyclosporine; Drug: ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00653276

2008_520

0653-057

MK0653-057

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Treatment A

Active Comparator group

Description:

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

Treatment:

Drug: Comparator: cyclosporine

Treatment B

Active Comparator group

Description:

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.

Treatment:

Drug: ezetimibe

Drug: Comparator: cyclosporine