NCT00653276CompletedPhase 1
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 13
- Primary Endpoint
- To evaluate the safety and tolerability of cyclosporine coadministered with ezetimibe vs. cyclosporine administered alone.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- 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
Arms & Interventions
Treatment B
Active Comparator
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.
Intervention: ezetimibe (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Completed
Phase 3
Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED)Diabetes Mellitus, Type 2NCT00551876Organon and Co214
Completed
Phase 4
Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476)AtherosclerosisHypercholesterolemiaCoronary Heart DiseaseNCT00651274Organon and Co144
Completed
Phase 1
Assessment of Potential Interaction Between Ezetimibe and Rosuvastatin in Healthy Subjects With High Cholesterol (P03317)HypercholesterolemiaAtherosclerosisNCT00651144Organon and Co40
Completed
Phase 3
Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)HypercholesterolemiaNCT00129402Organon and Co248
Completed
Phase 3
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)HypercholesterolemiaNCT00276458Organon and Co196