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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-08-15

No results posted yet for this study

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 \[TGA\]).

Conditions

  • Healthy

Interventions

DRUG

Milvexian

Milvexian will be administered orally.

BIOLOGICAL

4-Factor Prothrombin Complex Concentrate (4F-PCC)

4F-PCC will be administered intravenously.

BIOLOGICAL

Recombinant Human Factor VIIa (rFVIIa)

rFVIIa will be administered intravenously.

BIOLOGICAL

Placebo matching to 4F-PCC

Placebo matching to 4F-PCC will be administered intravenously.

BIOLOGICAL

Placebo matching to rFVIIa

Placebo matching to rFVIIa will be administered intravenously.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04543383 on ClinicalTrials.gov