MD Ezetimibe Cyclosporine Interaction - Full Text View

Sponsor:	Merck
Collaborator:	Schering-Plough
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00653276

Purpose

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	Intervention	Phase
Cholesterol	Drug: ezetimibe Drug: Comparator: cyclosporine	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Drug Information available for: Cyclosporine Cyclosporin Ezetimibe

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	November 2003
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653276

Sponsors and Collaborators

Merck

Schering-Plough

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

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:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00653276 History of Changes
Other Study ID Numbers:	2008_520, MK0653-057
Study First Received:	April 1, 2008
Last Updated:	April 13, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cyclosporins
Cyclosporine
Ezetimibe
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents

ClinicalTrials.gov processed this record on February 09, 2012