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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00766025

Enrollment

Registered

2008-10-03

Start date

2008-09-30

Completion date

2009-02-28

Last updated

2009-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CYP2C19 Poor, Extensive Metabolizers

Keywords

Taiwanese Subjects, CYP2C19, Poor Metabolizers, Extensive Metabolizers, Taiwanese Subjects identified as CYP2C19 Poor or Extensive Metabolizers

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.

Interventions

DRUGRosuvastatin Calcium

single oral dose on days 1, 4, 5, 6, 10-16, 17

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	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

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026