Effect of polymorphic CYP2C19 genotype on the pharmacokinetics and pharmacodynamics of clopidogrel in healthy subjects
| ISRCTN | ISRCTN39669611 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39669611 |
| Secondary identifying numbers | PGX-CPG-101 |
- Submission date
- 31/07/2007
- Registration date
- 17/09/2007
- Last edited
- 24/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ji-Young Park
Scientific
Scientific
126-1
Anam-dong 5-ga
Sungbuk-gu
Seoul
136-705
Korea, South
| Phone | +82 2 920 6288 |
|---|---|
| jypark21@korea.ac.kr |
Study information
| Study design | Open-label, parallel, multiple-dose comparative study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Effect of polymorphic CYP2C19 genotype on the pharmacokinetics and pharmacodynamics of clopidogrel in healthy subjects |
| Study objectives | To evaluate the pharmacogenetic effect of CYP2C19 gene on the Pharmacokinetics (PK) / Pharmacodynamics (PD) of clopidogrel. The original target was the patients with cardiovascular diseases taking clopidogrel. However, due to the limitation of enrollment the trial was conducted with healthy subjects with different CYP2C19 genotype to demonstrate that the effect of clopidogrel varies according to the patient's CYP2C19 genotype. |
| Ethics approval(s) | The Institutional Review Board of Anam Hospital, Korea University College of Medicine, Seoul, Korea, approved on 12 February 2007 (ref: AN-06151-001). |
| Health condition(s) or problem(s) studied | Cardiovascular diseases |
| Intervention | After a loading dose of clopidogrel (300 mg; oral), patients will take a standard dose of clopidogrel 75 mg once a day for 6 days. The following will be carried out: 1. Assessment of PK of clopidogrel and its metabolite SR26334 2. Measurement of the inhibition of ADP induced platelet aggregation by clopidogrel for 15 days 3. Evaluation of CYP2C19 phenotyping test using omperazole hydroxylation as a CYP2C19 probe |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | CYP2C19 gene |
| Primary outcome measure | Genetic association with biological effect of clopidogrel. |
| Secondary outcome measures | PK/PD relationship. |
| Overall study start date | 01/03/2007 |
| Completion date | 31/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 24 |
| Total final enrolment | 24 |
| Key inclusion criteria | 1. Healthy male subjects aged between 19 to 55 2. Wish to participate in the study 3. Informed consent for the trial |
| Key exclusion criteria | 1. A history of or currently active clinically significant cardiac (including clinically significant abnormalities on Electrocardiogram [ECG] according to Principal Investigator [PI]), pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurological disease 2. Heavy smoker and alcohol consumer 3. Use of anticoagulants or medication within the last 1 month |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 31/08/2007 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
126-1
Seoul
136-705
Korea, South
136-705
Korea, South
Sponsor information
Korea University (South Korea)
University/education
University/education
126-1
Anam-dong 5-ga
Sungbuk-gu
Seoul
136-705
Korea, South
| Phone | +82 2 920 5114 |
|---|---|
| webmaster@kumc.or.kr | |
| Website | http://www.korea.ac.kr/~eng/main.htm |
"ROR" |
https://ror.org/047dqcg40 |
Funders
Funder type
Government
Anam Hospital, Korea University College of Medicine
No information available
The Korea Health 21 Research and Development Project, Ministry of Health and Welfare (South Korea)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2008 | 24/05/2019 | Yes | No |
Editorial Notes
24/05/2019: Publication reference and total final enrolment added.
