Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 4 of 4)

Portola Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Healthy Volunteers

Treatments: Combination Product: PRT064445/Edoxaban; Combination Product: Placebo/Edoxaban; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03551743

12-502 Module 4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men or women between the ages of 18 and 45 years old

Exclusion criteria

• History (including family history) or symptoms of, or risk factors for bleeding
• History (including family history) of or risk factors for a hypercoagulable or thrombotic condition
• Absolute/relative contraindication to anticoagulation or treatment with specific anticoagulants
• History of major surgery, severe trauma or bone fracture within 3 months prior to dosing; or planned surgery within 1 month after dosing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

28 participants in 4 patient groups, including a placebo group

Module 4 (600 mg bolus)

Experimental group

Description:

600 mg PRT064445 given as a single IV bolus

Treatment:

Combination Product: PRT064445/Edoxaban

Combination Product: Placebo/Edoxaban

Module 4 (800 mg bolus + 480 mg infusion) 8mg/min

Experimental group

Description:

1280 mg PRT064445: 800 mg IV at \~30 mg/min, followed by a continuous infusion of 480 mg (4 mg /min over 60 minutes)

Treatment:

Combination Product: PRT064445/Edoxaban

Combination Product: Placebo/Edoxaban

Module 4 (800 mg bolus)

Experimental group

Description:

800 mg PRT064445 as a single IV bolus

Treatment:

Combination Product: PRT064445/Edoxaban

Combination Product: Placebo/Edoxaban

Module 4 Placebo

Placebo Comparator group

Description:

Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.

Treatment:

Drug: Placebo