NCT03330457

A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing

A Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered Andexanet After Dosing to Steady-State With Oral Betrixaban in Healthy Subjects

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Portola Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bleeding

Interventions

Type	Name	Description
BIOLOGICAL	Andexanet alfa (bolus)	fXa inhibitor antidote
DRUG	Betrixaban 80 mg PO QD	fXa inhibitor
BIOLOGICAL	Andexanet alfa (infusion IV)	fXa inhibitor antidote

Timeline

• Start date: 2015-08-06
• Primary completion: 2016-02-22
• Completion: 2016-02-22
• First posted: 2017-11-06
• Last updated: 2023-08-08
• Results posted: 2020-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study