Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Liuhuaqiao Hospital
• Collaborator: Guangdong Province, Department of Science and Technology
• Treatments: Atorvastatin; Atorvastatin Calcium

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.