Study in Taiwanese Subjects Identified as CYP2C19 Poor and Extensive Metabolizers Receiving Rosuvastatin
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00766025
First received: October 2, 2008
Last updated: February 27, 2009
Last verified: February 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
CYP2C19 Poor Extensive Metabolizers |
Drug: Rosuvastatin Calcium |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Blood levels of rosuvastatin in Taiwanese subjects identified as CYP2CIP poor and extensive metabolizers [ Time Frame: Scheduled times during the 18 days that the study drug is taken ] [ Designated as safety issue: No ]
- Blood levels for assessment of pharmacodynamic (lipid) parameters [ Time Frame: Days -1 and 18 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and tolerability of rosuvastatin in Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers [ Time Frame: Screening through completion of the study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2008 |
| Study Completion Date: | February 2009 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rosuvastatin Calcium |
Drug: Rosuvastatin Calcium
single oral dose on days 1, 4, 5, 6, 10-16, 17
|
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00766025
Locations
| Taiwan | |
| Research Site | |
| Taipei, Taiwan | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Regeio Mosquea-Garcia, MD | AstraZeneca |
| Study Director: | Robin Meng, MD, PhD | AstraZeneca |
| Principal Investigator: | Tzung-Dau Wang, MD | Northern Taiwan University Hospital |
More Information
No publications provided
| Responsible Party: | Michael Cressman, Medical Science Executive Director, Clinical Development, Cardiovascular, AstraZeneca Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00766025 History of Changes |
| Other Study ID Numbers: | D3560C00059, Rosuvastatin Calcium |
| Study First Received: | October 2, 2008 |
| Last Updated: | February 27, 2009 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by AstraZeneca:
|
Taiwanese Subjects CYP2C19 Poor Metabolizers Extensive Metabolizers Taiwanese Subjects identified as CYP2C19 Poor or Extensive Metabolizers |
Additional relevant MeSH terms:
|
Calcium, Dietary Rosuvastatin Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013