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

Health Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765855
• Other study ID #: 06-005
• Status: Completed
• Phase: Phase 1
• Start date: September 2007
• Est. completion date: October 2007

Study information

• Verified date: August 2023
• Source: Alexion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Volunteers

Intervention

Drug:
• Betrixaban single oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Portola Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean (max, tmax, AUC)		Over 336 hours
Secondary	Percent dose recovered in urine and feces		Over 336 hours