NCT04543383View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

July 27, 2020

Primary Completion Date

June 7, 2023

Study Completion Date

June 9, 2023

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.

Trial Locations (1)

NZ 9728

PRA Health Sciences, Groningen

All Listed Sponsors

lead

Janssen Research & Development, LLC

INDUSTRY

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 | Biotech Hunter | Biotech Hunter