Effects of a Double-Blind, Single Dose of PER977 Administered Alone, and Following a Single Dose of Edoxaban — PER977-P1  

Anticoagulant Reversal Clinical Trial

Official title: Phase I Evaluation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of a Double-Blind, Single Dose of PER977 Administered Alone, and Following a Single Dose of Edoxaban

Status Completed

Clinical Trial Summary

PER977 monotherapy and co-administration following 60 mg edoxaban will have an acceptable safety and tolerability profile with no impact on pro-coagulant biomarkers. A dose of PER977 that reverses the effects of edoxaban on the pharmacodynamic (PD) biomarkers (point of care prothrombin time [PoC-PT]), and/or secondary biomarkers (thromboelastography reaction time [TEG-R]) will be identified.

Clinical Trial Description

Normal subjects will be dosed with PER977 or placebo alone and 1 week later, they will be given a single dose of edoxaban followed in 3 hours by a single IV dose of PER977. The purpose is to show safety and tolerability of PER977 alone and when combined with a NOAC (edoxaban). The study will also provide some insight into the doses that may be required to reverse a steady state edoxaban. ;

Related Conditions & MeSH terms

• Anticoagulant Reversal
• Reversal of Edoxaban Induced Anticoagulation

• NCT number: NCT01826266
• Study type: Interventional
• Source: AMAG Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: July 2013
• Completion date: December 2013