Status:
TERMINATED
Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment
Lead Sponsor:
Portola Pharmaceuticals
Collaborating Sponsors:
Novartis
Conditions:
Renal Impairment
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its metabolite in patients with mild, moderate, and severe renal impairment compared to healthy volunteers.
Detailed Description
Multiple-dose, open-label parallel-group design in patients with mild, moderate or severe renal impairment and age (±7 years), sex and weight (±15% BMI) matched healthy subjects. * mild renal impairm...
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
- History of heart disease
- Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00984113
Start Date
September 1 2009
End Date
December 1 2009
Last Update
August 4 2023
Active Locations (2)
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1
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
2
NOCR-Knoxville
Knoxville, Tennessee, United States, 37920