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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653913
• Other study ID #: P03962
• Status: Completed
• Phase: Phase 1
• Start date: March 2004
• Est. completion date: September 2004

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• SCH 58235
SCH 58235 10 mg (once daily)
• pitavastatin
Pitavastatin 2 mg (once daily)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Adverse events, laboratory tests results, and vital signs.		Throughout study