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

Phase 1

Completed

• Conditions: CYP2C19 Poor; Extensive Metabolizers
• Interventions: Drug: Rosuvastatin Calcium

• Registration Number: NCT00766025
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Status Verified: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-27
• Last Update Posted: 2009-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin Calcium	Rosuvastatin Calcium	-

Primary Outcome Measures

Name	Time	Method
Blood levels of rosuvastatin in Taiwanese subjects identified as CYP2CIP poor and extensive metabolizers	Scheduled times during the 18 days that the study drug is taken
Blood levels for assessment of pharmacodynamic (lipid) parameters	Days -1 and 18

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of rosuvastatin in Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers	Screening through completion of the study

Trial Locations

Locations (1)

Research Site; 🇨🇳 Taipei, Taiwan