Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)

Study Overview
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Brief Summary
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This study was designed to evaluate the pharmacokinetic interaction and safety of coadministration of SCH 58235 (ezetimibe) and pitavastatin in healthy Japanese adult male subjects or adult male subjects having no obvious disease other than high cholesterol levels.

Official Title
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Evaluation of Potential for Pharmacokinetic Drug Interaction Between SCH 58235 and Pitavastatin

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: SCH 58235
* Drug: pitavastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male subjects meeting all the criteria below or adult male subjects having no obvious disease other than high cholesterol levels. Aged 20 years or over and 65 years or below when the informed consent is obtained. Weighing 50 kg or over and 80 kg or below on the day of the screening tests, with BMI [Body Mass Index: body weight (kg)/height (m)2] ranging from 16.5 to 27.5. Exclusion Criteria: Patients meeting any one of the following conditions are excluded from the study. Subjects with the triglyceride value at screening test exceeding 500 mg/dL. Subjects with past history of drug allergy (shock, anaphylactic symptom, and angioedema). Subjects with past history of alcohol or drug dependence. Subjects with past history of mental disorder. Subjects positive in the test for HBs antigen, HCV antibody, or HIV antibody or in the serological test for syphilis. Subjects who used any drug within 2 weeks of investigational product administration in Period 1. Subjects who have drawn more than 400 mL of blood within 12 weeks before administration day in Period 1. Subjects who participated in other study within 16 weeks of investigational product administration in Period 1 and was administered a investigational product. Subjects who cannot take contraceptive measures during the study period (from providing informed consent to completion of Period 3 examination) Subjects who the investigator judges are inappropriate to participate in the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>SCH 58235 (Period 1) Pitavastatin (Period 2) Coadministration (Period 3) | Drug: SCH 58235<br>* SCH 58235 10 mg (once daily)<br>* Other names: Ezetimibe;Drug: pitavastatin<br>* Pitavastatin 2 mg (once daily)<br>|
| Active Comparator: Group B<br>SCH 58235 (Period 1) Coadministration (Period 2) Pitavastatin (Period 3) | Drug: SCH 58235<br>* SCH 58235 10 mg (once daily)<br>* Other names: Ezetimibe;Drug: pitavastatin<br>* Pitavastatin 2 mg (once daily)<br>|
| Active Comparator: Group C<br>Pitavastatin (Period 1) SCH 58235 (Period 2) Coadministration (Period 3) | Drug: SCH 58235<br>* SCH 58235 10 mg (once daily)<br>* Other names: Ezetimibe;Drug: pitavastatin<br>* Pitavastatin 2 mg (once daily)<br>|
| Active Comparator: Group D<br>Pitavastatin (Period 1) Coadministration (Period 2) SCH 58235 (Period 3) | Drug: SCH 58235<br>* SCH 58235 10 mg (once daily)<br>* Other names: Ezetimibe;Drug: pitavastatin<br>* Pitavastatin 2 mg (once daily)<br>|
| Active Comparator: Group E<br>Coadministration (Period 1) SCH 58235 (Period 2) Pitavastatin (Period 3) | Drug: SCH 58235<br>* SCH 58235 10 mg (once daily)<br>* Other names: Ezetimibe;Drug: pitavastatin<br>* Pitavastatin 2 mg (once daily)<br>|
| Active Comparator: Group F<br>Coadministration (Period 1) Pitavastatin (Period 2) SCH 58235 (Period 3) | Drug: SCH 58235<br>* SCH 58235 10 mg (once daily)<br>* Other names: Ezetimibe;Drug: pitavastatin<br>* Pitavastatin 2 mg (once daily)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin after administration of each drug alone and in combination, using Cmax and AUC(0-24h). |  | Day 7 of each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin administration of each drug alone and in coadministration, using Tmax, plasma concentration 24 h after last dose, and AUC(I). |  | Day 7 of each period | 
| Adverse events, laboratory tests results, and vital signs. |  | Throughout study |