NCT03083704

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

A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Second Generation Andexanet Alfa Administered to Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Portola Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

• Bleeding

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-02-26
• Primary completion: 2017-09-28
• Completion: 2017-09-28
• First posted: 2017-03-20
• Last updated: 2023-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study