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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

CYP2C19 Poor

Extensive Metabolizers

Treatments

Drug: Rosuvastatin Calcium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00766025

D3560C00059

Rosuvastatin Calcium

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)