# 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

> **NCT02047565** · PHASE1 · COMPLETED · sponsor: **Daiichi Sankyo** · enrollment: 110 (actual)

## Conditions studied

- Bleeding

## Interventions

- **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

## Key facts

- **NCT ID:** NCT02047565
- **Lead sponsor:** Daiichi Sankyo
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-10
- **Primary completion:** 2014-05
- **Final completion:** 2014-05
- **Target enrollment:** 110 (ACTUAL)
- **Last updated:** 2019-02-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02047565

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/clinical/NCT02047565. Licensed CC0.

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