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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

December 28, 2012
January 8, 2013
September 2007
October 2007   (final data collection date for primary outcome measure)
mean (max, tmax, AUC) [ Time Frame: Over 336 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01765855 on ClinicalTrials.gov Archive Site
Percent dose recovered in urine and feces [ Time Frame: Over 336 hours ]
Same as current
Not Provided
Not Provided
 
An Open-Label, Single-Dose, Mass-Balance Study to Assess the Disposition of 14C-Labeled PRT054021 in Healthy Male Subjects
AN OPEN-LABEL, SINGLE-DOSE, MASS-BALANCE STUDY TO ASSESS THE DISPOSITION OF 14C-LABELED PRT054021 IN HEALTHY MALE SUBJECTS

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

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Health Volunteers
Drug: Betrixaban single oral dose
Experimental: Single Arm Oral Betrixaban
Intervention: Drug: Betrixaban single oral dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Male
19 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01765855
06-005
No
Portola Pharmaceuticals
Portola Pharmaceuticals
Not Provided
Not Provided
Portola Pharmaceuticals
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP