# 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** · PHASE1 · COMPLETED · sponsor: **Janssen Research & Development, LLC** · enrollment: 52 (actual)

## Conditions studied

- Healthy

## Interventions

- **DRUG:** Milvexian
- **BIOLOGICAL:** 4-Factor Prothrombin Complex Concentrate (4F-PCC)
- **BIOLOGICAL:** Recombinant Human Factor VIIa (rFVIIa)
- **BIOLOGICAL:** Placebo matching to 4F-PCC
- **BIOLOGICAL:** Placebo matching to rFVIIa

## Key facts

- **NCT ID:** NCT04543383
- **Lead sponsor:** Janssen Research & Development, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-07-27
- **Primary completion:** 2023-06-07
- **Final completion:** 2023-06-09
- **Target enrollment:** 52 (ACTUAL)
- **Last updated:** 2025-08-15


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04543383

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-06-26 from https://api.ai-analytics.org/clinical/NCT04543383. Licensed CC0.

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