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

AN OPEN-LABEL, SINGLE-DOSE, MASS-BALANCE STUDY TO ASSESS THE DISPOSITION OF 14C-LABELED PRT054021 IN HEALTHY MALE SUBJECTS

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01765855

Enrollment

Registered

2013-01-10

Start date

2007-09-30

Completion date

2007-10-31

Last updated

2023-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Volunteers

Keywords

Betrixaban, Healthy, Mass Balance

Brief summary

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

Interventions

DRUGBetrixaban single oral dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
mean (max, tmax, AUC)	Over 336 hours

Secondary

Measure	Time frame
Percent dose recovered in urine and feces	Over 336 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026