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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Portola Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01765868
First received: December 28, 2012
Last updated: January 8, 2013
Last verified: January 2013
  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: Open Label
Primary Purpose: Basic Science
Official Title: A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers.

Further study details as provided by Portola Pharmaceuticals:

Primary Outcome Measures:
  • Percent of orally absorbed dose [ Time Frame: over 72 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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

No publications provided

Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01765868     History of Changes
Other Study ID Numbers: 07-012
Study First Received: December 28, 2012
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Portola Pharmaceuticals:
Betrixaban
Healthy
Bioavailability

ClinicalTrials.gov processed this record on April 17, 2014