Population Pharmacokinetic Study of the Effect of Polymorphisms in the ABCB1 and CES1 Genes on the Pharmacokinetics of Dabigatran

The Affiliated Hospital Of Guizhou Medical University

Status: Not yet enrolling

Conditions: Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic Parameters

Treatments: Drug: Dabigatran Etexilate 150mg

Study type: Observational

Funder types: Other

Identifiers

NCT06387407

2024037K

Details and patient eligibility

About

According to published studies, the effects of genetic polymorphisms in the ABCB1 and CES1 genes on the blood concentration of dabigatran are controversial, and it is not clear whether dabigatran dosage and dosing intervals need to be adjusted according to genotype or other covariates in Chinese subjects. For these purposes, we will include patient demographics, genetic polymorphisms, and PK data based on a population pharmacokinetic study of dabigatran ester in healthy Chinese subjects to analyze the effect on dabigatran pharmacokinetics.

The aim of this study was to develop a population pharmacokinetic model to understand the relationship between dabigatran-related genes and dabigatran plasma levels after a single oral dose in healthy Chinese subjects and patients, and to analyze the effects of genetic variation on the efficacy and safety of dabigatran etexilate.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion and exclusion criteria for healthy subjects were consistent with bioequivalence studies.

Inclusion Criteria:

1. Age 18-89 years;
2. ECG meeting the diagnostic criteria for atrial fibrillation;
3. Provide at least one valid blood sample for SNP testing;
4. no contraindication to anticoagulation, blood counts and coagulation times within normal reference values, and negative urine and stool occult blood;
5. not have had any stroke in the 6 months prior to enrollment.

Exclusion Criteria:

1. Cardiac ultrasound suggestive of moderate-to-severe mitral stenosis or after mechanical valve replacement;
2. severe hepatic injury or renal insufficiency (estimated glomerular filtration rate [eGFR] <30 mL/(min*1.73m2))
3. History of stroke or peripheral arterial embolism during dosing;
4. patients at high risk of bleeding, such as history of bleeding, hematologic disorders, other disorders requiring anticoagulant therapy, peptic ulcer and other bleeding, and blood pressure >180/110 mmHg;
5. Combination of other serious diseases, such as malignant tumors, severe hepatic and renal insufficiency;
6. history of allergy to dabigatran and warfarin.