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:
Portola Pharmaceuticals
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
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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 May 23, 2013