Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin
Information source: Liuhuaqiao Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Heart Disease
Intervention: Atorvastatin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Liuhuaqiao Hospital Official(s) and/or principal investigator(s): Zhao Shujin, PhD, Study Director, Affiliation: Guangzhou General Hospital of Guangzhou Military Command
Summary
The aim of the study is to investigate the effects of CYP3A polymorphisms on the
pharmacokinetics of Atorvastatin in Chinese subjects with coronary heart disease.
Clinical Details
Official title: Study the Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin in Chinese Subjects With Coronary Heart Disease
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Compare the area under the plasma concentration versus time curve (AUC) and Area under the plasma concentration versus time curve (AUC) of atorvastatin with different CYP3A4*1G genotypes.
Secondary outcome: The pharmacokinetics of atorvastatin in Chinese with coronary heart disease.
Detailed description:
Large variability exists in the individual response to statins. CYP3A polymorphisms likely
contribute to variable response to those drugs primarily metabolized by CYP3A including
atorvastatin.
Eligibility
Minimum age: 35 Years.
Maximum age: 65 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Subjects must demonstrate their willingness to participate in the study and comply
with its procedures by signing a written informed consent.
- Subjects must be >=35 years and <=70 years of age.
- Subjects must have an LDL-C concentration >=2. 6 mmol/L and TC concentration >=4. 14
mmol/L
- Body mass index (BMI) must be within the range of 19 to 30 for patients.
- Subjects must have documented coronary heart disease with one or more of the
following features:
- Documented stable angina (with evidence of ischemia on exercise testing)
- History of myocardial infarction
- History of percutaneous coronary intervention (with or without stent placement)
- Documented history of unstable angina or non-Q wave myocardial infarction.
Exclusion Criteria:
- Diabetes and endocrine or metabolic disease.
- Congestive heart failure defined by New York Heart Association (NYHA) as Class III or
IV.
- Uncontrolled cardiac arrhythmia.
- Uncontrolled hypertension (Systolic BP >160 mm Hg and/or Diastolic BP >100 mmHg on
two consecutive measurements).
- Liver or kidney disease confirmed by abnormal lab values or function.
- Smokers who report cigarette use of more then 10 cigarette per day.
- Subjects who consume >2 alcoholic drinks a day. (A drink is: a can of beer, glass of
wine, or single measure of spirits).
- Known human immunodeficiency virus (HIV) positive.
- Cancer.
- Subjects who are on any of the following concomitant medications:
- Medications that are potent inhibitors of CYP3A, including cyclosporine,
itraconazole, fluconazole, and ketoconazole, erythromycin or clarithromycin,
nefazodone, protease inhibitors,mibefradil and large amounts of grapefruit juice
(>1 quart/day).
- Lipid-lowering agent: niacin (>200 mg/day) taken within 5 weeks, fibric acid
derivatives taken within 8 weeks.
Locations and Contacts
Guangzhou General Hospital of Guangzhou Military Command, Guangzhou, Guangdong 510010, China
Additional Information
Starting date: June 2009
Last updated: November 28, 2011
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