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

NCT00766025 | Completed Phase 1

• 2 other identifiers: D3560C00059Rosuvastatin Calcium
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

CYP2C19 Poor; Extensive Metabolizers

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety and tolerability of rosuvastatin in Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers

  Screening through completion of the study

Study Arms (1)

Rosuvastatin Calcium

EXPERIMENTAL

Drug: Rosuvastatin Calcium

Interventions

Rosuvastatin Calcium DRUG

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

Rosuvastatin Calcium

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Taipei, Taiwan

Location

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Regeio Mosquea-Garcia, MD

  AstraZeneca

  STUDY DIRECTOR

• Robin Meng, MD, PhD

  AstraZeneca

  STUDY DIRECTOR

• Tzung-Dau Wang, MD

  Northern Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: September 1, 2008
• Study Completion: February 1, 2009
• Last Updated: March 2, 2009

Record last verified: 2009-02

Locations

TW (1)