MD Ezetimibe Cyclosporine Interaction (0653-057)
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
3 other identifiers
interventional
13
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2003
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 1, 2008
CompletedFirst Posted
Study publicly available on registry
April 4, 2008
CompletedAugust 15, 2024
February 1, 2022
2 months
April 1, 2008
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (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.
Study Arms (2)
Treatment A
ACTIVE COMPARATORTreatment A: subjects will be given a single oral dose of cyclosporine 100 mg capsules on Day 1.
Treatment B
ACTIVE COMPARATORTreatment 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.
Interventions
ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.
single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
- Schering-Ploughcollaborator
Related Publications (1)
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. doi: 10.1177/0091270005284851.
PMID: 16490808BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2008
First Posted
April 4, 2008
Study Start
November 1, 2003
Primary Completion
January 1, 2004
Study Completion
January 1, 2004
Last Updated
August 15, 2024
Record last verified: 2022-02