A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants

• Status: Completed
• Trial end date: 2016-06-17

Summary

The purpose of this study is to assess the independent effects of both a 4-Factor prothrombin complex concentrate (PCC) - (Kcentra) and Tranexamic acid (TXA) on the bleeding parameters (bleeding duration and blood volume) following a punch biopsy, in addition to assessing their effects on the anticoagulant/pharmacodynamic (prothrombin time and endogenous thrombin potential) changes induced by rivaroxaban at steady state, to better understand their potential role in bleeding reversal.

• Phase: Phase 1

Details

• Lead Sponsor: Janssen Scientific Affairs, LLC
• Collaborator: Bayer
• Treatments: Protein C; Protein S; Rivaroxaban; Thrombin; Tranexamic Acid