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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study has four modules with a total of 21 cohorts, each module was reported and submitted separately.

Module 1, NCT01758432 (54 subjects with 7 cohorts including placebo); Module 2, NCT03578146 (48 subjects with 6 cohorts including placebo); Module 3, NCT03551730 (27 subjects with 4 cohorts including placebo); Module 4, NCT03551743 (28 subjects with 4 cohorts including placebo)

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Module 2 (210 mg)

210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)

Group Type EXPERIMENTAL

PRT064445/Rivaroxaban

Intervention Type COMBINATION_PRODUCT

Placebo/Rivaroxaban

Intervention Type COMBINATION_PRODUCT

Module 2 (420 mg)

420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)

Group Type EXPERIMENTAL

PRT064445/Rivaroxaban

Intervention Type COMBINATION_PRODUCT

Placebo/Rivaroxaban

Intervention Type COMBINATION_PRODUCT

Module 2 (600 mg)

600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)

Group Type EXPERIMENTAL

PRT064445/Rivaroxaban

Intervention Type COMBINATION_PRODUCT

Placebo/Rivaroxaban

Intervention Type COMBINATION_PRODUCT

Module 2 (720 mg bolus + 240 mg infusion)

720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)

Group Type EXPERIMENTAL

PRT064445/Rivaroxaban

Intervention Type COMBINATION_PRODUCT

Placebo/Rivaroxaban

Intervention Type COMBINATION_PRODUCT

Module 2 (800 mg bolus + 960 mg infusion)

800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]

Group Type EXPERIMENTAL

PRT064445/Rivaroxaban

Intervention Type COMBINATION_PRODUCT

Placebo/Rivaroxaban

Intervention Type COMBINATION_PRODUCT

Module 2 Placebo

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Interventions

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PRT064445/Rivaroxaban

Intervention Type COMBINATION_PRODUCT

Placebo/Rivaroxaban

Intervention Type COMBINATION_PRODUCT

Placebo

Intervention Type DRUG

Other Intervention Names

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Andexanet

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes