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

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 4 Placebo vs Module 4 (600mg); p = 0.0344; Least Squares Means (Difference) -65.02; ANCOVA NCT03551743 ↗

registry analysis (superiority test); Module 4 Placebo vs Module 4 (800 mg Bolus + 480 mg Infusion); p = 0.0014; Least Squares Means (Difference) -92.38; ANCOVA NCT03551743 ↗

registry analysis (superiority test); Module 4 Placebo vs Module 4 (800 mg); p = 0.0002; Least Squares Means (Difference) -46.26; ANCOVA NCT03551743 ↗

Publications

• Lu G, Conley PB, Leeds JM, Karbarz MJ, Levy GG, Mathur VS, Castillo J, Crowther M, Curnutte JT. A phase 2 PK/PD study of andexanet alfa for reversal of rivaroxaban and edoxaban anticoagulation in healthy volunteers. Blood Adv. 2020 Feb 25;4(4):728-739. doi: 10.1182/bloodadvances.2019000885.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Andexanet alfa	Protein / enzyme biologic	600 mg	Intravenous
Subject	Andexanet alfa	Protein / enzyme biologic	800 mg	Intravenous
Subject	Andexanet alfa	Protein / enzyme biologic	1280 mg	Intravenous
Background	Edoxaban	Small molecule	—	—

Indications

No indication recorded.