Overview

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

Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Portola Pharmaceuticals
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Betrixaban
Criteria
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