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A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01765868
First Posted: January 10, 2013
Last Update Posted: January 10, 2013
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
This is a open label, single center, single oral dose, study of PRT054021, in healthy subjects.

Condition Intervention Phase
Healthy Subjects Drug: Betrixaban Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers.

Resource links provided by NLM:


Further study details as provided by Portola Pharmaceuticals:

Primary Outcome Measures:
  • Percent of orally absorbed dose [ Time Frame: over 72 hours ]

Enrollment: 8
Study Start Date: September 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Oral and IV Betrixaban Drug: Betrixaban
Single Oral dose 80 mg betrixaban and Single IV (15 ml) carbon 14 80 micrograms Betrixaban administered over 15 minutes, 2 hours after the oral dose

  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 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult men ages of 19 and 65 years old, inclusive
  • BMI of 18-35 kg/m2

Exclusion Criteria:

  • Clinically significant comorbid disease
  • History of substance abuse
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01765868     History of Changes
Other Study ID Numbers: 07-012
First Submitted: December 28, 2012
First Posted: January 10, 2013
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by Portola Pharmaceuticals:
Betrixaban
Healthy
Bioavailability

Additional relevant MeSH terms:
Betrixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants