Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Coronary Heart Disease

Keywords

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atorvastatin genetic polymorphisms coronary heart disease pharmacokinetics CYP3A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CYP3A41/1

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

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.

CYP3A41/1G

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

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.

CYP3A41G/1G

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Lipitor Atorvastatin Calcium Tablets

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Guangzhou General Hospital of Guangzhou Military Command

Principal Investigators

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Zhao Shujin, PhD

Role: STUDY_DIRECTOR

Guangzhou General Hospital of Guangzhou Military Command

Locations

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Guangzhou General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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He BX, Shi L, Qiu J, Zeng XH, Zhao SJ. The effect of CYP3A4*1G allele on the pharmacokinetics of atorvastatin in Chinese Han patients with coronary heart disease. J Clin Pharmacol. 2014 Apr;54(4):462-7. doi: 10.1002/jcph.229. Epub 2013 Nov 27.

Reference Type DERIVED

PMID: 24214373 (View on PubMed)