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

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ClinicalTrials.gov Identifier: NCT01765855
Recruitment Status : Completed
First Posted : January 10, 2013
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):
Portola Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Health Volunteers Drug: Betrixaban single oral dose Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Betrixaban
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single Arm Oral Betrixaban Drug: Betrixaban single oral dose



Primary Outcome Measures :
  1. mean (max, tmax, AUC) [ Time Frame: Over 336 hours ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes 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

Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01765855     History of Changes
Other Study ID Numbers: 06-005
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: December 2012

Keywords provided by Portola Pharmaceuticals:
Betrixaban
Healthy
Mass Balance

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