Study in Taiwanese Subjects Identified as CYP2C19 Poor and Extensive Metabolizers Receiving Rosuvastatin

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00766025
First received: October 2, 2008
Last updated: February 27, 2009
Last verified: February 2009
  Purpose

The main purpose of this study is to examine Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers while taking single and multiple dosing a rosuvastatin calcium.


Condition Intervention Phase
CYP2C19 Poor
Extensive Metabolizers
Drug: Rosuvastatin Calcium
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase I, Open Label, Parallel Group, Single and Multiple Dose Study in Taiwanese Subjects Identified as CYP2C19 Poor Metabolizers or Extensive Metabolizers Receiving 20 Milligrams of Rosuvastatin Calcium

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Blood levels of rosuvastatin in Taiwanese subjects identified as CYP2CIP poor and extensive metabolizers [ Time Frame: Scheduled times during the 18 days that the study drug is taken ] [ Designated as safety issue: No ]
  • Blood levels for assessment of pharmacodynamic (lipid) parameters [ Time Frame: Days -1 and 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of rosuvastatin in Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers [ Time Frame: Screening through completion of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2008
Study Completion Date: February 2009
Arms Assigned Interventions
Experimental: Rosuvastatin Calcium Drug: Rosuvastatin Calcium
single oral dose on days 1, 4, 5, 6, 10-16, 17

  Eligibility

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

Inclusion Criteria:

  • Subject must have blood drawn for genotyping (determination of EM or PM of CYP2C19, determination of OATP-C1B1, BCRP 421C>A, and CYP2C9.
  • Males and females aged 20-65, inclusive
  • Women who are surgically sterilized, post-menopausal for at least one year, or not pregnant and/or lactating. Women of childbearing potential must be willing to abstain from sexual activity or use an effective contraception as outlined in protocol.

Exclusion Criteria:

  • Subjects with deoxyribonucleic acid (DNA) that codes for OATP-C 1B1 *5 and *15, BCRP 421C>A and/or non wild-type CYP2C9
  • History of adverse drug reaction or hypersensitivity to statins or drugs with a similar chemical structure to rosuvastatin
  • History or presence of gastrointestinal, hepatic, or renal disease or other conditions known to interfere with absorption, distribution, metabolism and excretion (ADME) of drugs
  • Any contraindication determined by review of a detailed medical and drug history, complete physical examination, vital signs, blood chemistry, hematology, and electrocardiogram (ECG)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766025

Locations
Taiwan
Research Site
Taipei, Taiwan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Regeio Mosquea-Garcia, MD AstraZeneca
Study Director: Robin Meng, MD, PhD AstraZeneca
Principal Investigator: Tzung-Dau Wang, MD Northern Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Michael Cressman, Medical Science Executive Director, Clinical Development, Cardiovascular, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00766025     History of Changes
Other Study ID Numbers: D3560C00059, Rosuvastatin Calcium
Study First Received: October 2, 2008
Last Updated: February 27, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by AstraZeneca:
Taiwanese Subjects
CYP2C19
Poor Metabolizers
Extensive Metabolizers
Taiwanese Subjects identified as CYP2C19 Poor or Extensive Metabolizers

Additional relevant MeSH terms:
Calcium, Dietary
Rosuvastatin
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014