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

February 27, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rosuvastatin Calcium
Drug: Rosuvastatin Calcium
single oral dose on days 1, 4, 5, 6, 10-16, 17

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Scheduled times during the 18 days that the study drug is taken
Blood levels for assessment of pharmacodynamic (lipid) parameters
Time Frame: Days -1 and 18
Days -1 and 18

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of rosuvastatin in Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers
Time Frame: Screening through completion of the study
Screening through completion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

October 2, 2008

First Submitted That Met QC Criteria

October 2, 2008

First Posted (Estimate)

October 3, 2008

Study Record Updates

Last Update Posted (Estimate)

March 2, 2009

Last Update Submitted That Met QC Criteria

February 27, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3560C00059
  • Rosuvastatin Calcium

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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