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 - NCT00759564-46260(Clinical Trial 243329)
ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.
| City: |
|
Indianapolis |
|
State:
|
|
IN |
| Zip Code: |
|
46260 |
| Conditions: |
|
Pneumonia |
| Purpose: |
|
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).
|
| Study summary: |
|
To evaluate the pharmacokinetics and safety. |
| Criteria: |
|
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. |
|
|
|
|
|
|
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
April 13, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|