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

NCT01765868 | Completed Phase 1

• 1 other identifier: 07-012
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Subjects

Keywords

Betrixaban; Healthy; Bioavailability

Outcome Measures

Primary Outcomes (1)

• Percent of orally absorbed dose

  over 72 hours

Study Arms (1)

Single Arm Oral and IV Betrixaban

EXPERIMENTAL

Drug: Betrixaban

Interventions

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

Single Arm Oral and IV Betrixaban

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult men ages of 19 and 65 years old, inclusive
• BMI of 18-35 kg/m2

You may not qualify if:

• Clinically significant comorbid disease
• History of substance abuse

Sponsors & Collaborators

• Portola Pharmaceuticals: lead

MeSH Terms

Interventions

betrixaban

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2012
• First Posted: January 10, 2013
• Study Start: September 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: August 8, 2023

Record last verified: 2023-08