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

PHASE1CompletedINTERVENTIONAL

Enrollment

110

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

May 31, 2014

Study Completion Date

May 31, 2014

Conditions

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

Trial Locations (1)

Quintiles, Overland Park