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

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00653913
Collaborator
(none)
18
Enrollment
6
Arms
6
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Potential for Pharmacokinetic Drug Interaction Between SCH 58235 and Pitavastatin
Study Start Date :
Mar 1, 2004
Actual Primary Completion Date :
Sep 1, 2004
Actual Study Completion Date :
Sep 1, 2004

Arms and Interventions

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)

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. 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]

    2. Adverse events, laboratory tests results, and vital signs. [Throughout study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT00653913
    Other Study ID Numbers:
    • P03962
    First Posted:
    Apr 7, 2008
    Last Update Posted:
    Feb 16, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Hypercholesterolemia
    Ezetimibe
    Pitavastatin

    Study Results

    No Results Posted as of Feb 16, 2022