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
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: 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 October 22, 2014