Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Evaluation
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
Following a first, dose ascending study that enrolled 144 normal healthy volunteers (NHVs),
this study, to be conducted in approximately 36 NHVs, will provide pertinent information in
determining the dose-response of MDCO-157 for platelet aggregation inhibition and P2Y12
receptor inhibition effects and in selection of doses that match the antiplatelet effects of
300 mg PLAVIX® ®. The study will also provide additional data for pharmacokinetics (PK),
safety and tolerability of single doses of MDCO-157.