MD Ezetimibe Cyclosporine Interaction (0653-057)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00653276
• Collaborator: Schering-Plough (Industry)
• Enrollment: 13
• Arms: 2
• Duration (Months): 2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cholesterol	Drug: ezetimibe; Drug: Comparator: cyclosporine	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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
• Study Start Date: Nov 1, 2003
• Actual Primary Completion Date: Jan 1, 2004
• Actual Study Completion Date: Jan 1, 2004

Arms and Interventions

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: 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.

Outcome Measures

Primary Outcome Measures

1. To evaluate the safety and tolerability of cyclosporine coadministered with ezetimibe vs. cyclosporine administered alone. [Blood sampling will be conducted for 48 hours starting with the first cyclosporine dosing.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co
• Schering-Plough

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00653276
• Other Study ID Numbers: 0653-057; MK0653-057; 2008_520
• First Posted: Apr 4, 2008
• Last Update Posted: Feb 18, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Cyclosporine; Ezetimibe; Cyclosporins

Study Results

No Results Posted as of Feb 18, 2022