NCT00973986CompletedPhase 1
Study the Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin in Chinese Subjects With Coronary Heart Disease
Liuhuaqiao Hospital1 site in 1 country20 target enrollmentStarted: June 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
CYP3A4*1/*1
Active Comparator
Intervention: Atorvastatin (Drug)
CYP3A4*1/*1G
Active Comparator
Intervention: Atorvastatin (Drug)
CYP3A4*1G/*1G
Active Comparator
Intervention: Atorvastatin (Drug)
Outcomes
Primary Outcomes
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.
Time Frame: 48h
Secondary Outcomes
- The pharmacokinetics of atorvastatin in Chinese with coronary heart disease.(48h)
Investigators
Study Sites (1)
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