Conditions: Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
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: 210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min) arm 2: 420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min) arm 3: 600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min) arm 4: 720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min) arm 5: 800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\] arm 6: Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous fusion.

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

Protocol document: