NCT02047565

A Two-part Study in Edoxaban-treated Healthy Subjects to Establish a Punch Biopsy Bleeding Model and to Evaluate the Effect of a 4-factor Prothrombin Complex Concentrate on Anticoagulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This Phase 1 study consists of 2 parts. Part 1 will be an open-label, randomized, 2 treatment, 2-way crossover study. Part 2 will be a double-blind (Sponsor unblinded), randomized, placebo controlled, sequential descending prothrombin complex concentrate dose, 2 sequence, 2 period crossover study. In both parts of the study, the assessor of BD and BV will remain blinded. In Part 2 of the study, both the subject and the clinic staff involved in study conduct will be blinded (with the exception of the pharmacist or nurse who prepares the blinded individual treatments from open-label supplies). The study programmer and statistician will also be blinded to treatment assignment. The Sponsor will remain unblinded for both parts of the study.

Conditions

• Bleeding

Interventions

Type	Name	Description
DRUG	60mg edoxaban
DRUG	180mg edoxaban
DRUG	50 IU/kg Beriplex P/N
DRUG	25 IU/kg Beriplex P/N
DRUG	10 IU/kg Beriplex P/N

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-01-28
• Last updated: 2019-02-12

Locations

1 site across 1 country: United States