A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment

Portola Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Betrixaban

Study type: Interventional

Funder types: Industry

Identifiers

NCT00999336

08-016

Details and patient eligibility

About

The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Able to understand and sign the written informed consent.
• Subjects should have either normal renal function or have stable renal disease

Exclusion criteria

• Subjects require dialysis
• Evidence of active bleeding or bleeding disorder
• Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Group H

Active Comparator group

Description:

Healthy subjects matched to the renal impairment groups

Treatment:

Drug: Betrixaban

Group A

Experimental group

Description:

Patients with mild renal impairment

Treatment:

Drug: Betrixaban

Group B

Experimental group

Description:

Patients with moderate renal impairment

Treatment:

Drug: Betrixaban

Group C

Experimental group

Description:

Patients with severe renal impairment

Treatment:

Drug: Betrixaban