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

Phase 1

Completed

• Conditions: Health Volunteers
• Interventions: Drug: Betrixaban single oral dose

• Registration Number: NCT01765855
• Lead Sponsor: Portola Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Study First Submitted: 2012-12-28
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-10
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Oral Betrixaban	Betrixaban single oral dose	-

Primary Outcome Measures

Name	Time	Method
mean (max, tmax, AUC)	Over 336 hours

Secondary Outcome Measures

Name	Time	Method
Percent dose recovered in urine and feces	Over 336 hours