A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2017
This is a randomized, double-blind, study in healthy volunteers dosed to steady state with fXa inhibitors, designed to (1) demonstrate PK/PD comparability between andexanet manufactured by the Generation 1 and Generation 2 processes, (2) evaluate the degree to which the Generation 2 andexanet reverses fXa-inhibitor-induced anticoagulation in comparison to placebo, and (3) evaluate safety of Generation 2 andexanet.
Epistemonikos ID: aaa785c2a34eeb1c2b2e31d64023ae095a449b3c
First added on: May 20, 2024