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



Status:Completed
Conditions:Pneumonia, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:November 2008
End Date:March 2010

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An Open-label, 2-way Crossover Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Iv Cp-70429 And Oral Pf-03709270 In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function

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).

To evaluate the pharmacokinetics and safety.

Inclusion Criteria:

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 Criteria:

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.
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Bruxelles,
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Indianapolis, Indiana 46260
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Indianapolis, IN
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