Status:
COMPLETED
A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function
Lead Sponsor:
Pfizer
Conditions:
Pneumonia
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
This study will evaluate what effect renal dysfunction has on a drug that has an intravenous (CP-70,429) and an oral form (PF-03709270).
Detailed Description
To evaluate the pharmacokinetics and safety.
Eligibility Criteria
Inclusion
- Subjects must meet one of the following renal function categories:
- Normal renal function (CLcr \>80 mL/min).
- Mild renal impairment (CLcr \>50 and \<80 mL/min).
- Moderate renal impairment (CLcr \>30 and \<50 mL/min).
- Severe renal impairment (CLcr \<30 mL/min).
Exclusion
- Women who are pregnant or nursing or women who are of childbearing potential. History of clinically significant allergies, including seasonal allergies, and especially drug hypersensitivity including known allergies to components of the study drug formulation, penicillin, carbapenems and/or cephalosporin antibiotics (eg, amoxicillin, amoxicillin/clavulanate, ampicillin, cefadroxil, cephalexin, cefaclor and cefixime).
- Subjects should not have evidence of a history of the following:
- normal renal function: clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological or allergic disease.
- renal impairment: any clinically significant (hepatic, cardiac or pulmonary or subjects with acute nephritic syndrome) diseases (except diabetes). Stable co-morbid disease where it is unlikely that the disease and medication will alter the outcome of the study will be allowed.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00759564
Start Date
November 1 2008
End Date
March 1 2010
Last Update
March 11 2016
Active Locations (2)
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1
Centurion Clinical Research
Indianapolis, Indiana, United States, 46260
2
Pfizer Clinical Research Unit
Brussels, Belgium, 1070