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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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CYP2C19 Poor, Extensive Metabolizers

Intervention / Treatment
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* Drug: Rosuvastatin Calcium


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Taiwanese Subjects, CYP2C19, Poor Metabolizers, Extensive Metabolizers, Taiwanese Subjects identified as CYP2C19 Poor or Extensive Metabolizers