Phase 1 study of novel anti-platelet agent to overcome pharmacogenomic limitations of clopidogrel.

ABSTRACT:

Aims

Clopidogrel is the most commonly prescribed thienopyridine as part of dual anti-platelet therapy for the treatment of cardiovascular diseases. However, clopidogrel responsiveness shows variability based on CYP2C19 polymorphism. Therefore, we planned a study with an objective of evaluating safety, tolerability, pharmacodynamics and pharmacokinetics of a novel thienopyridine antiplatelet agent AT-10 in healthy Indian subjects compared with standard dosage regimen of clopidogrel based on their CYP2C19 genotyping.

Methods

Two CYP2C19 genotype-based groups were identified, that is, poor metabolisers and extensive metabolisers, with 20 subjects in each group (n=40) for participating in a randomised, two-period, crossover study. Each study period lasted 6 days including admini

SUBMITTER: Pareek A 

PROVIDER: S-EPMC11815446 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature