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

NCT ID: NCT01765855

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2007-10-31

Brief Summary

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

Conditions

Health Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single Arm Oral Betrixaban

Group Type: EXPERIMENTAL

Betrixaban single oral dose

Intervention Type: DRUG

Interventions

Betrixaban single oral dose

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Portola Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

06-005

Identifier Type: -

Identifier Source: org_study_id