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Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote

NCT ID: NCT03218241

Last Updated: 2023-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-10-31

Brief Summary

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This is a single center, double-blind, randomized, placebo-controlled, ascending, single dose study of PRT064445 or its matching placebo, in healthy subjects.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PRT0064445 Dose 1

Dose 1 versus Placebo

Group Type EXPERIMENTAL

PRT064445

Intervention Type BIOLOGICAL

Intravenous

Placebo

Intervention Type DRUG

Intravenous to mimic PRT064445

PRT064445 Dose 2

Dose 2 versus Placebo

Group Type EXPERIMENTAL

PRT064445

Intervention Type BIOLOGICAL

Intravenous

Placebo

Intervention Type DRUG

Intravenous to mimic PRT064445

PRT064445 Dose 3

Dose 3 versus Placebo

Group Type EXPERIMENTAL

PRT064445

Intervention Type BIOLOGICAL

Intravenous

Placebo

Intervention Type DRUG

Intravenous to mimic PRT064445

PRT064445 Dose 4

Dose 4 versus Placebo

Group Type EXPERIMENTAL

PRT064445

Intervention Type BIOLOGICAL

Intravenous

Placebo

Intervention Type DRUG

Intravenous to mimic PRT064445

PRT064445 Dose 5

Dose 5 versus Placebo

Group Type EXPERIMENTAL

PRT064445

Intervention Type BIOLOGICAL

Intravenous

Placebo

Intervention Type DRUG

Intravenous to mimic PRT064445

Interventions

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PRT064445

Intravenous

Intervention Type BIOLOGICAL

Placebo

Intravenous to mimic PRT064445

Intervention Type DRUG

Other Intervention Names

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Placebo (for PRT064445)

Eligibility Criteria

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Inclusion Criteria

* Healthy men or women between the ages of 18 and 50 years old, inclusive
* BMI 19-32 and weighs at least 60kgs

Exclusion Criteria

* History or symptoms of bleeding problems or thrombotic conditions
* Clinically significant medical history
* Major surgery, severe trauma, or bone fracture within 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Portola Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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11-501

Identifier Type: -

Identifier Source: org_study_id

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