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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00472836 |
CP-945,598 is eliminated following extensive metabolism. For some drugs, decreased renal (kidney) function can affect their elimination from the body via metabolism. This study will therefore compare the pharmacokinetics (time course of drug concentrations in the body), safety and tolerability of CP-945,598 in patients with severe renal impairment and healthy control subjects.
Condition | Intervention | Phase |
---|---|---|
Obesity |
Drug: CP-945,598 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Phase 1, Open-Label, Parallel Group, Multiple-Dose Study To Evaluate The Pharmacokinetics, Safety And Toleration Of CP-945,598 Administered To Subjects With Severely Impaired And Normal Renal Function |
Enrollment: | 17 |
Study Start Date: | July 2007 |
Study Completion Date: | October 2008 |
Arms | Assigned Interventions |
---|---|
Normal renal function: Experimental |
Drug: CP-945,598
Administration of CP-945,598 in subjects with normal renal function.
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Severe renal impairment: Experimental |
Drug: CP-945,598
Administration of CP-945,598 in subjects with severe renal impairment.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Stable dose of medication and/or treatment. 4. Reasonably well-controlled type 1 and type 2 diabetics
Exclusion Criteria:
United States, California | |
Pfizer Investigational Site | |
Anaheim, California, United States, 92801 | |
United States, Florida | |
Pfizer Investigational Site | |
Miami, Florida, United States, 33169 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A5351038 |
Study First Received: | May 11, 2007 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00472836 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |