Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 54
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, and pharmacodynamics of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect fXa inhibitors in healthy volunteers

Arms:
arm 1: 90 mg PRT064445 given as a single IV arm 2: 210 mg PRT064445 given as a single IV bolus arm 3: 420 mg PRT064445 given as a single IV bolus arm 4: 600 mg PRT064445 given as follows: 420 mg IV over \~14 minutes (\~30 mg/min), followed by a continuous infusion of 180 mg (4 mg/min over 45 minutes) arm 5: 600 mg PRT064445 given as follows: up to 420 mg IV over \~14 minutes (\~30 mg/min), followed by a second bolus of 180 mg IV over \~6 minutes (\~30 mg/min), 45 minutes after completion of the bolus arm 6: 900 mg PRT064445 given as follows: 420 mg IV, followed by a continuous infusion of 480 mg (4 mg/min over 120 minutes arm 7: Placebo administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.

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

Protocol document: