Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4)

Portola Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Healthy Volunteers

Treatments

Drug: Placebo

Combination Product: PRT064445/Apixaban

Combination Product: Placebo/Apixaban

Study type

Interventional

Funder types

Industry

Identifiers

NCT01758432

12-502 Module 1

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, and pharmacodynamics of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect fXa inhibitors in healthy volunteers

Enrollment

54 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

54 participants in 7 patient groups, including a placebo group

Module 1 (90 mg bolus)

Experimental group

Description:

90 mg PRT064445 given as a single IV

Treatment:

Combination Product: PRT064445/Apixaban

Combination Product: Placebo/Apixaban

Module 1 (210 mg bolus)

Experimental group

Description:

210 mg PRT064445 given as a single IV bolus

Treatment:

Combination Product: PRT064445/Apixaban

Combination Product: Placebo/Apixaban

Module 1 (420 mg bolus)

Experimental group

Description:

420 mg PRT064445 given as a single IV bolus

Treatment:

Combination Product: PRT064445/Apixaban

Combination Product: Placebo/Apixaban

Module 1 (420 mg bolus + 180 mg infusion) 4 mg/min

Experimental group

Description:

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)

Treatment:

Combination Product: PRT064445/Apixaban

Combination Product: Placebo/Apixaban

Module 1 (420 mg bolus + 180 mg bolus) 30mg/min

Experimental group

Description:

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

Treatment:

Combination Product: PRT064445/Apixaban

Combination Product: Placebo/Apixaban

Module 1 (420 mg bolus + 480 mg infusion) 4mg/min

Experimental group

Description:

900 mg PRT064445 given as follows: 420 mg IV, followed by a continuous infusion of 480 mg (4 mg/min over 120 minutes

Treatment:

Combination Product: PRT064445/Apixaban

Combination Product: Placebo/Apixaban

Module 1 Placebo

Placebo Comparator group