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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00645021 |
CP-945,598 is eliminated following extensive metabolism. Decrease hepatic function can affect its 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 mild and moderate hepatic impairment and healthy control subjects.
Condition | Intervention | Phase |
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Obesity Hepatic Insufficiency |
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 Impaired And Normal Hepatic Function |
Enrollment: | 24 |
Study Start Date: | April 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Mild hepatic function: Experimental |
Drug: CP-945,598
Administration of CP-945,598 in subjects with mild hepatic function
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Moderate hepatic function: Experimental |
Drug: CP-945,598
Administration of CP-945,598 in subjects with moderate hepatic function
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Normal hepatic function: Experimental |
Drug: CP-945,598
Administration of CP-945,598 in subjects with normal hepatic function
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
stable hepatic disease: no changes in the last 30 days. 3. stable dose of medication and/or treatment.
Exclusion Criteria:
United States, Florida | |
Pfizer Investigational Site | |
Miami, Florida, United States, 33169 | |
Pfizer Investigational Site | |
Orlando, Florida, United States, 32809 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A5351029 |
Study First Received: | March 21, 2008 |
Last Updated: | August 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00645021 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Body Weight Signs and Symptoms Obesity Liver Diseases Digestive System Diseases |
Nutrition Disorders Overweight Overnutrition Hepatic Insufficiency |
Body Weight Signs and Symptoms Obesity Liver Diseases Digestive System Diseases |
Nutrition Disorders Overweight Overnutrition Hepatic Insufficiency |