Coronary Heart DiseasePhase 1ECGPPANCT00973986
Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin
A Phase 1 study testing Atorvastatin in people with Coronary Heart Disease, run by Liuhuaqiao Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men only
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010
About this study
Official title: Study the Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin in Chinese Subjects With Coronary Heart Disease
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.
Read the 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.
- Conditions
- Coronary Heart Disease
- Being tested
- Atorvastatin
- Keywords
- atorvastatin, genetic polymorphisms, coronary heart disease, pharmacokinetics, CYP3A
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor, Atorvastatin Calcium Tablets
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.
| Study group | Role | What they receive |
|---|---|---|
| CYP3A4*1/*1 | Active comparator | Not described Receives: Drug: Atorvastatin |
| CYP3A4*1/*1G | Active comparator | Not described Receives: Drug: Atorvastatin |
| CYP3A4*1G/*1G | Active comparator | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48h
Secondary outcomes (1)
The pharmacokinetics of atorvastatin in Chinese with coronary heart disease.
Measured: 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liuhuaqiao Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Province, Department of Science and Technology
- Investigators
- Zhao Shujin, PhD, Study director, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973986
- Sponsor's protocol ID
- YWLCSY-0900328
- Other IDs
- 08110831, GZJQZYY-003, ATR-01, GD080625, 20081001
- Acronym
- ECGPPA
- Status last verified
- Sep 2009
- First submitted
- 4 Sep 2009
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24214373
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin in Chinese Subjects With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00973986
- Acronym / sponsor ID
- ECGPPA / YWLCSY-0900328
- Conditions
- Coronary Heart Disease
- Keywords
- atorvastatin, genetic polymorphisms, coronary heart disease, pharmacokinetics, CYP3A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Liuhuaqiao HospitalUniversity, hospital or other
- Collaborators
- Guangdong Province, Department of Science and Technology
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CYP3A4*1/*1 | Active comparator | Drug: Atorvastatin |
| CYP3A4*1/*1G | Active comparator | Drug: Atorvastatin |
| CYP3A4*1G/*1G | Active comparator | Drug: Atorvastatin |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Lipitor, Atorvastatin Calcium TabletsThe 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. | Drug | CYP3A4*1/*1, CYP3A4*1/*1G, CYP3A4*1G/*1G |
Primary outcome
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
1 secondary outcome
The pharmacokinetics of atorvastatin in Chinese with coronary heart disease.
Time frame: 48h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2011.
- Derived from this study: PubMed 24214373He 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhao Shujin, PhD study director
Guangzhou General Hospital of Guangzhou Military Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atorvastatin in people with Coronary Heart Disease, run by Liuhuaqiao Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00973986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2011.