clinical trial · NCT03083704
A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa
Portola Pharmaceuticals·phase1·completed·n = 153
BleedingAndexanet alfa (Gen 1 Process 2)Apixaban 5 MGRivaroxaban 20 MGEnoxaparin sodiumEdoxaban 60 MGAndexanet alfa (Gen 2)Andexanet alfa (Gen 1 Process 3)Apixaban 10 MG
brief summary
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.
started
Feb 26, 2017
primary completion
Sep 28, 2017
completion
Sep 28, 2017
last updated
Aug 8, 2023
official title
A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Second Generation Andexanet Alfa Administered to Healthy Subjects
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol