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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subjects

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betrixaban

Drug

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

Primary outcomes

Percent of orally absorbed dose

Time frame: over 72 hours

Sponsors and collaborators

Lead sponsor

Portola Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Jan 10, 2013
Registry last updated: Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed