Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin (ECGPPA)

Liuhuaqiao Hospital

Status and phase

Completed

Phase 1

Conditions

Coronary Heart Disease

Treatments

Drug: Atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00973986

GD080625

YWLCSY-0900328

08110831

GZJQZYY-003

20081001

ATR-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Male

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

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.