Status:
COMPLETED
Study in Taiwanese Subjects Identified as CYP2C19 Poor and Extensive Metabolizers Receiving Rosuvastatin
Lead Sponsor:
AstraZeneca
Conditions:
CYP2C19 Poor
Extensive Metabolizers
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00766025
Start Date
September 1 2008
End Date
February 1 2009
Last Update
March 2 2009
Active Locations (1)
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1
Research Site
Taipei, Taiwan