A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing
Status:
Terminated
Trial end date:
2016-02-22
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, single center study in healthy volunteers dosed to steady
state with betrixaban, designed to (1) Determine an andexanet dosing regimen required to
reverse anticoagulant activity of betrixaban in healthy subjects, (2) Assess the safety and
tolerability of andexanet vs. placebo (3) Determine the PK properties of andexanet and
betrixaban (4) Determine the PD properties of betrixaban before, during, and after receiving
andexanet or placebo and (5) Investigate the immunogenicity of andexanet in the presence of
betrixaban.