Study in Taiwanese Subjects Identified as CYP2C19 Poor and Extensive Metabolizers Receiving Rosuvastatin
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: CYP2C19 Poor; Extensive Metabolizers
Intervention: Rosuvastatin Calcium (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Regeio Mosquea-Garcia, MD, Study Director, Affiliation: AstraZeneca
Robin Meng, MD, PhD, Study Director, Affiliation: AstraZeneca
Tzung-Dau Wang, MD, Principal Investigator, Affiliation: Northern Taiwan University Hospital
Overall contact:
AstraZeneca Clinical Study, Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
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.
Clinical Details
Official title: 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
Study design: Basic Science, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Blood levels of rosuvastatin in Taiwanese subjects identified as CYP2CIP poor and extensive metabolizersBlood levels for assessment of pharmacodynamic (lipid) parameters
Secondary outcome: Safety and tolerability of rosuvastatin in Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
AstraZeneca Clinical Study, Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Research Site, Taipei, Taiwan; Recruiting
Additional Information
Starting date: September 2008
Ending date: January 2009
Last updated: October 3, 2008
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