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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Pneumonia

Treatments: Drug: CP-70,429 and PF-03709270

Study type: Interventional

Funder types: Industry

Identifiers

NCT00759564

2009-017796-20 (EudraCT Number)

A8811009

Details and patient eligibility

About

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).

Full description

To evaluate the pharmacokinetics and safety.

Enrollment: 29 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

29 participants in 1 patient group

IV CP-70,429 and cross over to PF-03709270

Experimental group

Treatment:

Drug: CP-70,429 and PF-03709270