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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Betrixaban

• Registration Number: NCT01765868
• 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: 2023-08-07
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Oral and IV Betrixaban	Betrixaban	-

Primary Outcome Measures

Name	Time	Method
Percent of orally absorbed dose	over 72 hours