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 is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Portola Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Portola Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01758432
First received: December 18, 2012
Last updated: December 31, 2012
Last verified: December 2012
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 144
Study Start Date: December 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRT064445 Biological: PRT064445
Other Name: Comparison of PRT064445 with placebo
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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758432

Contacts
Contact: Study Clinical Trial Contact 855-256-7070 fXaantidote@portola.com

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

No publications provided

Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01758432     History of Changes
Other Study ID Numbers: 12-502
Study First Received: December 18, 2012
Last Updated: December 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Portola Pharmaceuticals:
Healthy volunteers

ClinicalTrials.gov processed this record on July 22, 2014