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

Portola Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Health Volunteers

Treatments: Drug: Betrixaban single oral dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01765855

06-005

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Single Arm Oral Betrixaban

Experimental group

Treatment:

Drug: Betrixaban single oral dose