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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01765868

Enrollment

Registered

2013-01-10

Start date

2007-09-30

Completion date

2007-10-31

Last updated

2023-08-08

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

Conditions

Healthy Subjects

Keywords

Betrixaban, Healthy, Bioavailability

Brief summary

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

Interventions

DRUGBetrixaban

Single Oral dose 80 mg betrixaban and Single IV (15 ml) carbon 14 80 micrograms Betrixaban administered over 15 minutes, 2 hours after the oral dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Percent of orally absorbed dose	over 72 hours

Outcome results

None listed

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