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

August 3, 2023 updated by: Portola Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445, a Factor Xa (fXa) Inhibitor Antidote

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRT0064445 Dose 1
Dose 1 versus Placebo
Biological: PRT064445
Intravenous
Drug: Placebo
Intravenous to mimic PRT064445
Other Names:
  • Placebo (for PRT064445)
Experimental: PRT064445 Dose 2
Dose 2 versus Placebo
Biological: PRT064445
Intravenous
Drug: Placebo
Intravenous to mimic PRT064445
Other Names:
  • Placebo (for PRT064445)
Experimental: PRT064445 Dose 3
Dose 3 versus Placebo
Biological: PRT064445
Intravenous
Drug: Placebo
Intravenous to mimic PRT064445
Other Names:
  • Placebo (for PRT064445)
Experimental: PRT064445 Dose 4
Dose 4 versus Placebo
Biological: PRT064445
Intravenous
Drug: Placebo
Intravenous to mimic PRT064445
Other Names:
  • Placebo (for PRT064445)
Experimental: PRT064445 Dose 5
Dose 5 versus Placebo
Biological: PRT064445
Intravenous
Drug: Placebo
Intravenous to mimic PRT064445
Other Names:
  • Placebo (for PRT064445)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamics assessments
Time Frame: Up to 28 days
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: Plasma levels of PRT064445
Time Frame: Up to 7 days
Up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portola Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 27, 2012

First Submitted That Met QC Criteria

July 12, 2017

First Posted (Actual)

July 14, 2017

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11-501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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