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

Portola Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Betrixaban

Study type: Interventional

Funder types: Industry

Identifiers

NCT01765868

07-012

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Single Arm Oral and IV Betrixaban

Experimental group

Treatment:

Drug: Betrixaban