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NCT01765868 Clinical Trial

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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01765868
Other study ID # 07-012
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2007
Est. completion date October 2007

Study information
Verified date August 2023
Source Alexion
Contact n/a
Is FDA regulated No
Health authority
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 8
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Betrixaban
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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Portola Pharmaceuticals

Outcome
Type Measure Description Time frame Safety issue
Primary Percent of orally absorbed dose over 72 hours
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