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

Organon

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia

Treatments: Drug: SCH 58235; Drug: pitavastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00653913

P03962

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 6 patient groups

Group A

Active Comparator group

Description:

SCH 58235 (Period 1) Pitavastatin (Period 2) Coadministration (Period 3)

Treatment:

Drug: pitavastatin

Drug: SCH 58235

Group B

Active Comparator group

Description:

SCH 58235 (Period 1) Coadministration (Period 2) Pitavastatin (Period 3)

Treatment:

Drug: pitavastatin

Drug: SCH 58235

Group C

Active Comparator group

Description:

Pitavastatin (Period 1) SCH 58235 (Period 2) Coadministration (Period 3)

Treatment:

Drug: pitavastatin

Drug: SCH 58235

Group D

Active Comparator group

Description:

Pitavastatin (Period 1) Coadministration (Period 2) SCH 58235 (Period 3)

Treatment:

Drug: pitavastatin

Drug: SCH 58235

Group E

Active Comparator group

Description:

Coadministration (Period 1) SCH 58235 (Period 2) Pitavastatin (Period 3)

Treatment:

Drug: pitavastatin

Drug: SCH 58235

Group F

Active Comparator group

Description:

Coadministration (Period 1) Pitavastatin (Period 2) SCH 58235 (Period 3)

Treatment:

Drug: pitavastatin

Drug: SCH 58235