An Open-Label, Single-Dose, Mass-Balance Study to Assess the Disposition of 14C-Labeled PRT054021 in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Portola Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01765855
First received: December 28, 2012
Last updated: January 8, 2013
Last verified: December 2012
  Purpose

This is a open label, single center, single oral dose, study of PRT054021, in healthy subjects.


Condition Intervention Phase
Health Volunteers
Drug: Betrixaban single oral dose
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: AN OPEN-LABEL, SINGLE-DOSE, MASS-BALANCE STUDY TO ASSESS THE DISPOSITION OF 14C-LABELED PRT054021 IN HEALTHY MALE SUBJECTS

Further study details as provided by Portola Pharmaceuticals:

Primary Outcome Measures:
  • mean (max, tmax, AUC) [ Time Frame: Over 336 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent dose recovered in urine and feces [ Time Frame: Over 336 hours ]

Enrollment: 5
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 Betrixaban Drug: Betrixaban single oral dose

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult men ages of 19 and 55 years old, inclusive
  • weighs at least 132 lbs

Exclusion Criteria:

  • Clinically significant comorbid disease
  • History of substance abuse
  • Hemoglobin less than 12.0 g/dl
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01765855     History of Changes
Other Study ID Numbers: 06-005
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
Mass Balance

ClinicalTrials.gov processed this record on April 17, 2014