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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: SCH 58235; Drug: pitavastatin

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Actual): September 1, 2004
• Study Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: March 31, 2008
• First Submitted That Met QC Criteria: April 4, 2008
• First Posted (Estimate): April 7, 2008

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Ezetimibe; Pitavastatin
• Other Study ID Numbers: P03962