Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin (ECGPPA)
This study has been completed.
Sponsor:
Liuhuaqiao Hospital
Collaborator:
Guangdong Province, Department of Science and Technology
Information provided by:
Liuhuaqiao Hospital
ClinicalTrials.gov Identifier:
NCT00973986
First received: September 4, 2009
Last updated: November 28, 2011
Last verified: September 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Heart Disease |
Drug: Atorvastatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Study the Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin in Chinese Subjects With Coronary Heart Disease |
Resource links provided by NLM:
Further study details as provided by Liuhuaqiao Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The pharmacokinetics of atorvastatin in Chinese with coronary heart disease. [ Time Frame: 48h ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | June 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: CYP3A4*1/*1 |
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:
|
| Active Comparator: CYP3A4*1/*1G |
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:
|
| Active Comparator: CYP3A4*1G/*1G |
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:
|
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.
Eligibility| Ages Eligible for Study: | 35 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973986
Locations
| China, Guangdong | |
| Guangzhou General Hospital of Guangzhou Military Command | |
| Guangzhou, Guangdong, China, 510010 | |
Sponsors and Collaborators
Liuhuaqiao Hospital
Guangdong Province, Department of Science and Technology
Investigators
| Study Director: | Zhao Shujin, PhD | Guangzhou General Hospital of Guangzhou Military Command |
More Information
No publications provided
| Responsible Party: | Department of pharmacy, Guangzhou General Hospital of Guangzhou Military Command |
| ClinicalTrials.gov Identifier: | NCT00973986 History of Changes |
| Other Study ID Numbers: | YWLCSY-0900328, 08110831, GZJQZYY-003, ATR-01, GD080625, 20081001 |
| Study First Received: | September 4, 2009 |
| Last Updated: | November 28, 2011 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Liuhuaqiao Hospital:
|
atorvastatin genetic polymorphisms coronary heart disease pharmacokinetics CYP3A |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Atorvastatin |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013