drugset / Trial / NCT03310021

A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects

NCT03310021

Phase 2 Completed 108 enrolled Portola Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

Summary

"This is a single-center, randomized, double-blind, and placebo-controlled trial designed to: 1) demonstrate the degree to which administered andexanet doses can reverse Factor Ten A (FXa)-inhibitor induced anticoagulation; and 2) evaluate the safety and PK/PD of andexanet in healthy Japanese subjects taking direct FXa inhibitors at therapeutic doses."

Timeline

Start
2017-08-28
Primary completion
2019-08-13
Completion
2019-08-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Andexanet alfa Protein / enzyme biologic Intravenous
Subject Apixaban Small molecule
Subject Edoxaban Small molecule
Subject Rivaroxaban Other / unclassified

Indications