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

Completed Phase 1 Last updated 8 February 2019

What this trial tests

Phase 1 trial testing 60mg edoxaban in Bleeding in 110 participants. Completed in 1 May 2014.

Timeline

1 October 2013

Primary endpoint
1 May 2014

1 May 2014

Quick facts

Lead sponsor	Daiichi Sankyo
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	supportive care
Enrollment	110
Start date	1 October 2013
Primary completion	1 May 2014
Estimated completion	1 May 2014
Sites	1 location across United States

Drugs / interventions tested

• 60mg edoxaban — full drug profile →
• 180mg edoxaban — full drug profile →
• 50 IU/kg Beriplex P/N — full drug profile →
• 25 IU/kg Beriplex P/N — full drug profile →
• 10 IU/kg Beriplex P/N — full drug profile →

Conditions studied

• Bleeding — all drugs for Bleeding →

Sponsor

Daiichi Sankyo — full company profile →

Who can join

Adults 18 to 45, any sex, with Bleeding. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Bleeding duration 60mg edoxaban
  Time frame: Day 1
  To assess the variability and effect size of bleeding duration (BD) following punch biopsy in healthy subjects administered 60 mg edoxaban
• Bleeding volume 60mg edoxaban
  Time frame: Day 1
  To assess the variability and effect size of bleeding volume (BV) following punch biopsy in healthy subjects administered 60 mg edoxaban
• Bleeding duration 180mg edoxaban
  Time frame: Day 1
  To assess the variability and effect size of bleeding duration (BD) following punch biopsy in healthy subjects administered 180 mg edoxaban
• Bleeding volume 180mg edoxaban
  Time frame: Day 1
  To assess the variability and effect size of bleeding volume (BV) following punch biopsy in healthy subjects administered 180 mg edoxaban

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Edoxaban effects on bleeding following punch biopsy and reversal by a 4-factor prothrombin complex concentrate.
   Zahir H, Brown KS, Vandell AG, Desai M, et al · · 2015 · cited 175× · PMID 25403645 · DOI 10.1161/circulationaha.114.013445