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

NCT03083704 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2023-08-08

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Andexanet alfa (Gen 1 Process 2)

factor Xa inhibitor antidote

DRUG

Apixaban 5 MG

factor Xa inhibitor

DRUG

Rivaroxaban 20 MG

factor Xa inhibitor

DRUG

Enoxaparin sodium

low molecular weight heparin

DRUG

Edoxaban 60 MG

factor Xa inhibitor

BIOLOGICAL

Andexanet alfa (Gen 2)

factor Xa inhibitor antidote

BIOLOGICAL

Andexanet alfa (Gen 1 Process 3)

factor Xa inhibitor antidote

DRUG

Apixaban 10 MG

factor Xa inhibitor

DRUG

Rivaroxaban 10 MG

factor Xa inhibitor

Sponsors & Collaborators

  • Portola Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-02-26
Primary Completion
2017-09-28
Completion
2017-09-28
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 NCT03083704 on ClinicalTrials.gov