drugset
drugset / Trial / NCT04543383

A Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Participants

NCT04543383 ↗

Phase 1 Completed 52 enrolled Janssen Research & Development, LLC
RandomizedCrossoverOpen-labelTreatment

Summary

The primary purpose of this study is to evaluate the reversal of the anticoagulant effects of milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) and Recombinant Human Factor VIIa (rFVIIa) in healthy participants as measured by changes from baselines of the coagulation testing parameters (activated partial thromboplastin time \[aPTT\] and thrombin generation assay \[TGA\]).

Timeline

Start
2020-07-27
Primary completion
2023-06-07
Completion
2023-06-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Milvexian Small molecule — Oral
Subject Prothrombin Complex Concentrate Protein / enzyme biologic — Intravenous
Subject Recombinant Human Factor VIIa Protein / enzyme biologic — Intravenous

Indications

No indication recorded.