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

NCT00653913 | Completed Phase 1

• 1 other identifier: P03962
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (6)

Group A

ACTIVE COMPARATOR

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

Drug: SCH 58235; Drug: pitavastatin

Group B

ACTIVE COMPARATOR

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

Drug: SCH 58235; Drug: pitavastatin

Group C

ACTIVE COMPARATOR

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

Drug: SCH 58235; Drug: pitavastatin

Group D

ACTIVE COMPARATOR

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

Drug: SCH 58235; Drug: pitavastatin

Group E

ACTIVE COMPARATOR

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

Drug: SCH 58235; Drug: pitavastatin

Group F

ACTIVE COMPARATOR

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

Drug: SCH 58235; Drug: pitavastatin

Interventions

SCH 58235 DRUG

SCH 58235 10 mg (once daily)

Also known as: Ezetimibe

Group A; Group B; Group C; Group D; Group E; Group F

pitavastatin DRUG

Pitavastatin 2 mg (once daily)

Group A; Group B; Group C; Group D; Group E; Group F

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe; pitavastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 7, 2008
• Study Start: March 1, 2004
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: February 16, 2022

Record last verified: 2022-02