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Completed

NCT Number: NCT00653913

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

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.

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Key information

Age range

20 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCH 58235

Drug

SCH 58235 10 mg (once daily)

Other names: Ezetimibe

Pitavastatin

Drug

Pitavastatin 2 mg (once daily)

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).

    Time frame: Day 7 of each period

Secondary outcomes

  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).

    Time frame: Day 7 of each period

  2. Adverse events, laboratory tests results, and vital signs.

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Apr 7, 2008
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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