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A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01765868
Recruitment Status : Completed
First Posted : January 10, 2013
Last Update Posted : January 10, 2013
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
Healthy Subjects Drug: Betrixaban Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers.
Study Start Date : September 2007
Primary Completion Date : October 2007
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 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

Primary Outcome Measures :
  1. Percent of orally absorbed dose [ Time Frame: over 72 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Portola Pharmaceuticals Identifier: NCT01765868     History of Changes
Other Study ID Numbers: 07-012
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by Portola Pharmaceuticals:

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