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

NCT03330457 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-08-08

Study results available
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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

Interventions

BIOLOGICAL

Andexanet alfa (bolus)

fXa inhibitor antidote

DRUG

Betrixaban 80 mg PO QD

fXa inhibitor

BIOLOGICAL

Andexanet alfa (infusion IV)

fXa inhibitor antidote

Sponsors & Collaborators

  • Portola Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-06
Primary Completion
2016-02-22
Completion
2016-02-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03330457 on ClinicalTrials.gov