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
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.

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 October 23, 2014