Trials / Completed
CompletedNCT04543383
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
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
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 54 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-07-27
- Primary completion
- 2023-06-07
- Completion
- 2023-06-09
- First posted
- 2020-09-10
- Last updated
- 2025-08-15
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04543383. Inclusion in this directory is not an endorsement.