Conditions: Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 28
Healthy volunteers: yes

Brief summary:
The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.

Detailed description:
A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect factor Xa (fXa) inhibitors in healthy volunteers.

Arms:
arm 1: 600 mg PRT064445 given as a single IV bolus arm 2: 1280 mg PRT064445: 800 mg IV at \~30 mg/min, followed by a continuous infusion of 480 mg (4 mg /min over 60 minutes) arm 3: 800 mg PRT064445 as a single IV bolus arm 4: Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.

Interventions: intervention 1: PRT064445/Edoxaban intervention 2: Placebo/Edoxaban intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: