Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2003-11-30
2004-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment A
Treatment A: subjects will be given a single oral dose of cyclosporine 100 mg capsules on Day 1.
Comparator: cyclosporine
single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.
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.
ezetimibe
ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.
Comparator: cyclosporine
single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.
Interventions
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ezetimibe
ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.
Comparator: cyclosporine
single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is judged to be in good health on the basis of history, physical examination, and routine laboratory data
Exclusion Criteria
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Schering-Plough
INDUSTRY
Organon and Co
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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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.
Other Identifiers
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MK0653-057
Identifier Type: -
Identifier Source: secondary_id
2008_520
Identifier Type: -
Identifier Source: secondary_id
0653-057
Identifier Type: -
Identifier Source: org_study_id
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