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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01758432
First Posted: January 1, 2013
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Portola Pharmaceuticals
  Purpose
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.

Condition Intervention Phase
Healthy Volunteers Biological: PRT064445 Biological: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Portola Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacodynamics assessments(thrombin generation and anti-fXa activity) [ Time Frame: Multiple time points over 48 days ]

Secondary Outcome Measures:
  • Pharmacokinetics: Plasma levels of PRT064445 [ Time Frame: over 8 days following study drug administration ]

Enrollment: 54
Study Start Date: December 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRT064445 (same as Andexanet) Biological: PRT064445
Other Name: Andexanet
Placebo Comparator: Placebo Biological: Placebo

Detailed 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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758432


Locations
United States, Arizona
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Portola Pharmaceuticals
  More Information

Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01758432     History of Changes
Other Study ID Numbers: 12-502
First Submitted: December 18, 2012
First Posted: January 1, 2013
Last Update Posted: October 2, 2017
Last Verified: September 2015

Keywords provided by Portola Pharmaceuticals:
Healthy volunteers