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

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00653913

Purpose

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	Intervention	Phase
Hypercholesterolemia	Drug: SCH 58235 Drug: pitavastatin	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of Potential for Pharmacokinetic Drug Interaction Between SCH 58235 and Pitavastatin

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Drug Reactions

Drug Information available for: Pitavastatin NK 104 Ezetimibe

U.S. FDA Resources

Further study details as provided by Schering-Plough:

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). [ Time Frame: Day 7 of each period ] [ Designated as safety issue: No ]

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). [ Time Frame: Day 7 of each period ] [ Designated as safety issue: No ]
Adverse events, laboratory tests results, and vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	March 2004
Study Completion Date:	September 2004
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group A SCH 58235 (Period 1) Pitavastatin (Period 2) Coadministration (Period 3)	Drug: SCH 58235 SCH 58235 10 mg (once daily) Other Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Ezetimibe Drug: pitavastatin Pitavastatin 2 mg (once daily)

Eligibility

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

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00653913 History of Changes
Other Study ID Numbers:	P03962
Study First Received:	March 31, 2008
Last Updated:	April 4, 2008
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pitavastatin
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012