MD Ezetimibe Cyclosporine Interaction (0653-057)

• ClinicalTrials.gov Identifier: NCT00653276
• Recruitment Status: Completed
• First Posted: April 4, 2008
• Last Update Posted: March 10, 2017
• Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Schering-Plough
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

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 (Clinical Trial)
• 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: November 2003
• Actual Primary Completion Date: January 2004
• Actual Study Completion Date: January 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. [ Time Frame: Blood sampling will be conducted for 48 hours starting with the first cyclosporine dosing. ]

Eligibility Criteria

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

Criteria

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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Schering-Plough

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

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: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00653276
• Other Study ID Numbers: 0653-057; MK0653-057; 2008_520
• First Posted: April 4, 2008
• Last Update Posted: March 10, 2017
• Last Verified: March 2017

Additional relevant MeSH terms:

Cyclosporine; Ezetimibe; Cyclosporins; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antifungal Agents; Anti-Infective Agents; Dermatologic Agents; Antirheumatic Agents; Calcineurin Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Lipid Regulating Agents