Back to resultsEvaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SCH 58235
pitavastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Group D
Group E
Group F
Arm Description
SCH 58235 (Period 1) Pitavastatin (Period 2) Coadministration (Period 3)
SCH 58235 (Period 1) Coadministration (Period 2) Pitavastatin (Period 3)
Pitavastatin (Period 1) SCH 58235 (Period 2) Coadministration (Period 3)
Pitavastatin (Period 1) Coadministration (Period 2) SCH 58235 (Period 3)
Coadministration (Period 1) SCH 58235 (Period 2) Pitavastatin (Period 3)
Coadministration (Period 1) Pitavastatin (Period 2) SCH 58235 (Period 3)
Outcomes
Primary Outcome Measures
Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin after administration of each drug alone and in combination, using Cmax and AUC(0-24h).
Secondary Outcome Measures
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).
Adverse events, laboratory tests results, and vital signs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00653913
Brief Title
Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)
Official Title
Evaluation of Potential for Pharmacokinetic Drug Interaction Between SCH 58235 and Pitavastatin
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
SCH 58235 (Period 1) Pitavastatin (Period 2) Coadministration (Period 3)
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
SCH 58235 (Period 1) Coadministration (Period 2) Pitavastatin (Period 3)
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Pitavastatin (Period 1) SCH 58235 (Period 2) Coadministration (Period 3)
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
Pitavastatin (Period 1) Coadministration (Period 2) SCH 58235 (Period 3)
Arm Title
Group E
Arm Type
Active Comparator
Arm Description
Coadministration (Period 1) SCH 58235 (Period 2) Pitavastatin (Period 3)
Arm Title
Group F
Arm Type
Active Comparator
Arm Description
Coadministration (Period 1) Pitavastatin (Period 2) SCH 58235 (Period 3)
Intervention Type
Drug
Intervention Name(s)
SCH 58235
Other Intervention Name(s)
Ezetimibe
Intervention Description
SCH 58235 10 mg (once daily)
Intervention Type
Drug
Intervention Name(s)
pitavastatin
Intervention Description
Pitavastatin 2 mg (once daily)
Primary Outcome Measure Information:
Title
Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin after administration of each drug alone and in combination, using Cmax and AUC(0-24h).
Time Frame
Day 7 of each period
Secondary Outcome Measure Information:
Title
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).
Time Frame
Day 7 of each period
Title
Adverse events, laboratory tests results, and vital signs.
Time Frame
Throughout study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)
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