Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4)

Phase 2 Completed 54 enrolled Portola Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.

Timeline

Start: 2012-12
Primary completion: 2015-09
Completion: 2015-09

Outcome

Met primary endpoint

registry analysis (superiority test); Module 1 Placebo vs Module 1 ( 90 mg); p <0.0001; Least Squares Means (Difference) -95.74; ANCOVA NCT01758432 ↗

Publications

Siegal D, Lu G, Leeds JM, Karbarz M, Castillo J, Mathur V, Hutchaleelaha A, Sinha U, Kitt M, McClure M, Hollenbach SJ, Curnutte JT, Conley PB, Crowther M. Safety, pharmacokinetics, and reversal of apixaban anticoagulation with andexanet alfa. Blood Adv. 2017 Sep 22;1(21):1827-1838. doi: 10.1182/bloodadvances.2017007112. eCollection 2017 Sep 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Andexanet alfa	Protein / enzyme biologic	90 mg	Intravenous
Subject	Andexanet alfa	Protein / enzyme biologic	210 mg	Intravenous
Subject	Andexanet alfa	Protein / enzyme biologic	420 mg	Intravenous
Subject	Andexanet alfa	Protein / enzyme biologic	600 mg	Intravenous
Subject	Andexanet alfa	Protein / enzyme biologic	900 mg	Intravenous
Background	Apixaban	Small molecule	5 mg	—

Indications

No indication recorded.