Daiichi Sankyo of Tokyo and Eli Lilly have suspended the enrollment of new patients and administration of the drug in two small prasugrel-related pharmacodynamic clinical trials until protocol amendments can be completed and approved.
The amendments are due to preliminary results from pharmacokinetic analyses, including patients and healthy subjects/volunteers, indicating that a dose adjustment is appropriate for certain subpopulations.
The amendments do not represent the outcome of the prasugrel clinical development program, according to the Indianapolis-based Eli Lilly.
The two Phase II pharmacodynamic studies aim to compare the levels of inhibition of platelet aggregation in patients with coronary artery disease taking the investigational antiplatelet agent prasugrel or clopidogrel (Plavix). Neither study has an efficacy endpoint.
The companies said that patient enrollment will resume when the analyses of pharmacokinetic and clinical data are completed, and the institutional review boards amend and approve the protocols.