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
Completed · Phase 1
Conditions studied: Pneumonia
In brief
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).
Key facts
- Study ID
- NCT00759564
- Run by
- Pfizer
- People needed
- 29
- Starts
- 2008-11-01
- Expected to finish
- 2010-03-01
- Last updated by the study team
- 2016-03-11
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Centurion Clinical Research — Indianapolis, Indiana, United States
- Pfizer Clinical Research Unit — Brussels, Belgium
Full record on ClinicalTrials.gov
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