Trial | NCT00973986  Report issue

Title

Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin
Study the Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin in Chinese Subjects With Coronary Heart Disease

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
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.
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.
Study Started
Jun 30
2009
Primary Completion
Dec 31
2010
Study Completion
Mar 31
2011
Last Update
Nov 29
2011
Estimate

Drug Atorvastatin

The subjects will receive atorvastatin (20 mg single dose) orally with approximately 240 ml of water. Blood samples(4 mL) will be taken prior to dosing and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24 and 48 h after drug administration.

  • Other names: Lipitor, Atorvastatin Calcium Tablets

CYP3A4*1/*1 Active Comparator

CYP3A4*1/*1G Active Comparator

CYP3A4*1G/*1G Active Comparator

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.
No Results Posted