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

NCT06387407 | Not Yet Recruiting

• 1 other identifier: 2024037K
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic Parameters

Outcome Measures

Primary Outcomes (1)

• Plasma drug concentration

  Blood samples collected 10-16 hours after the previous dose were considered trough plasma levels of dabigatran, and blood samples collected 1-3 hours after the dose were considered peak plasma levels.

  3 day

Interventions

Dabigatran Etexilate 150mg DRUG

Oral dabigatran etexilate capsules, 150 mg twice a day.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects in the dabigatran etexilate bioequivalence study; patients with nonvalvular atrial fibrillation (NVAF).

You may not qualify if:

• Age 18-89 years;
• ECG meeting the diagnostic criteria for atrial fibrillation;
• Provide at least one valid blood sample for SNP testing;
• no contraindication to anticoagulation, blood counts and coagulation times within normal reference values, and negative urine and stool occult blood;
• not have had any stroke in the 6 months prior to enrollment.
• Cardiac ultrasound suggestive of moderate-to-severe mitral stenosis or after mechanical valve replacement;
• severe hepatic injury or renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<30 mL/(min\*1.73m2))
• History of stroke or peripheral arterial embolism during dosing;
• 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;
• Combination of other serious diseases, such as malignant tumors, severe hepatic and renal insufficiency;
• history of allergy to dabigatran and warfarin.

Sponsors & Collaborators

• The Affiliated Hospital Of Guizhou Medical University: lead

MeSH Terms

Interventions

Dabigatran

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: May 1, 2024
• Primary Completion: June 10, 2025
• Study Completion: November 25, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04