A Two-Part, Open-Label, Randomized, Placebo-Controlled Crossover 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 Subjects

  • STATUS
    Recruiting
  • participants needed
    46
  • sponsor
    Janssen Research & Development, LLC
Updated on 30 January 2023
Accepts healthy volunteers

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]).

Details
Condition Healthy
Treatment JNJ-70033093, 4-Factor Prothrombin Complex Concentrate (4F-PCC), Recombinant Human Factor VIIa (rFVIIa), Placebo matching to 4F-PCC, Placebo matching to rFVIIa, Milvexian
Clinical Study IdentifierNCT04543383
SponsorJanssen Research & Development, LLC
Last Modified on30 January 2023

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