Skip to main content
OpenTrials
Completed

NCT Number: NCT01765855

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

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

Health Volunteers

Age range

19 year–55 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 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

Treatment and study plan

Betrixaban single oral dose

Drug

Primary outcomes

  1. mean (max, tmax, AUC)

    Time frame: Over 336 hours

Secondary outcomes

  1. Percent dose recovered in urine and feces

    Time frame: Over 336 hours

Sponsors and collaborators

Lead sponsor

Portola Pharmaceuticals

Industry

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 10, 2013
Registry last updated
Aug 4, 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.

Related clinical trials

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