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

PHASE1CompletedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

February 26, 2017

Primary Completion Date

September 28, 2017

Study Completion Date

September 28, 2017

Conditions
Bleeding
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

Trial Locations (1)

90630

West Coast Clinical Trials, Cypress

Sponsors
All Listed Sponsors
lead

Portola Pharmaceuticals

INDUSTRY