A Study to Explore the Pharmacodynamic Changes When Transitioning From Rivaroxaban to Warfarin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to explore the pharmacodynamic (what the drug does to the body)
      changes when transitioning from rivaroxaban 20 mg once daily to warfarin dosed to a
      therapeutic level as measured by the International Normalized Ratio (INR) range of 2.0 to 3.0
      in healthy volunteers. In addition, the pharmacokinetics (what the body does to the drug),
      safety and tolerability of rivaroxaban during the transition to warfarin will be
      investigated. The INR is obtained from a blood test, and is a measure for the clotting
      tendency of the blood used for safe and adequate dosing of warfarin.
    

Detailed description: 
      This is a single-center, open-label (study staff and healthy volunteers will know the
      identity of treatment assigned), sequential 2-treatment period study in healthy adult
      volunteers to explore the pharmacodynamic changes (changes drugs have on the body),
      specifically in regard to blood coagulation (blood clotting) when healthy volunteers take
      oral (by mouth) rivaroxaban followed by warfarin. Treatment Period 1: Rivaroxaban 20 mg/day
      for 5 days then Rivaoxaban 20 mg/day + Warfarin 10 mg/day for 2-4 days then warfarin 0-15
      mg/day for 4 days. Treatment Period 2: Warfarin 10 mg/day for 2-4 days, then 0-15 mg/day for
      4 days. Treatment periods 1 and 2 will be separated by a washout period of at least 14 days.
      In Treatment Periods 1 and 2, the dose of warfarin may be adjusted as specified by the
      protocol and the last dose of warfarin in each Treatment period will be followed by a single
      dose of Vitamin K. The approximate total study length for healthy adult volunteers enrolled
      is approximately 72 days (includes a 28-day Screening Period, a 30-day Open-label Treatment
      Phase, which includes the 7 days for a follow-up visit, and at least a 14-day washout between
      treatment periods).
    

Intervention name(s): Rivaroxaban; Warfarin; Vitamin K; Vitamin K; Warfarin; Warfarin; Warfarin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Type=exact number, unit=mg, number=20, form=tablet, route=oral use. One tablet once daily for 5 days (Treatment Period 1, Days 1-7).; Type=exact number, unit mg, number=10, form=tablet , route=oral use. One tablet for 2-4 days (Treatment Period 1, Day 6 up to Day 11).; Type=exact number, unit=mg, number=1, form=oral solution, route=oral use. 1 mg dose for 1 day (Treatment Period 1, Day 12).; Type=exact number, unit=mg, number=5, form=oral solution, route=oral use. 5 mg dose for 1 day (Treatment Period 2, Day 7).; Type-exact number, unit=mg, number=10, form=tablet, route=oral use. Tablet(s) administered once daily for 2-4 days (Treatment Period 2, Day 1 up to Day 6); Type=range, unit=mg, number=0-15, form=tablet, route=oral use. Tablet(s) taken once daily for up to 4 days after Warfarin 10 mg administered as monotherapy for 2-4 days (Treatment Period 1).; Type=range, unit=mg, number=0-15, form=tablet, route=oral use. Tablet(s) taken once daily for up to 4 days after Warfarin 10 mg administered as monotherapy for 2-4 days (Treatment Period 2).
Intervention MeSH terms: Vitamins; Vitamin K; Warfarin; Rivaroxaban
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rivaroxaban; JNJ-39039039; BAY59-7939; Warfarin; Transition