Status:
COMPLETED
A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
Lead Sponsor:
Portola Pharmaceuticals
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Renal Impairment
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- Able to understand and sign the written informed consent.
- Subjects should have either normal renal function or have stable renal disease
Exclusion
- 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
Key Trial Info
Start Date :
July 31 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00999336
Start Date
July 31 2009
End Date
February 28 2010
Last Update
August 22 2023
Active Locations (1)
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1
APEX GmbH
Munich, Germany