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

Phase 1CompletedNCT01765855

Portola Pharmaceuticals5 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Health Volunteers

Interventions

Betrixaban single oral doseDRUG

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

mean (max, tmax, AUC)

Time frame: Over 336 hours

Secondary Outcomes

Percent dose recovered in urine and feces

Time frame: Over 336 hours

Data from ClinicalTrials.gov

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