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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00706537 |
CP-945598 is a potent and selective Cannabinoid-1 (CB1) receptor antagonist currently being developed for the treatment of obesity. CP-945598 is also being considered as a potential treatment for non-alcoholic steatohepatitis (NASH). This study will investigate the steady-state safety, toleration and pharmacokinetics of multiple oral dose administration of CP-945598. Results will be used to estimate the pharmacokinetic characteristics in NASH patients and underwrite the safety of this compound prior to any further studies in NASH patients.
Condition | Intervention | Phase |
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Non Alcoholic Steato Hepatitis (NASH) |
Drug: Active treatment Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Multiple Dose, Randomized, Double-Blind (3rd Party Open), Placebo-Controlled Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of CP-945598 In Subjects With Nonalcoholic Steatohepatitis (NASH) |
Enrollment: | 9 |
Study Start Date: | July 2008 |
Study Completion Date: | November 2008 |
Arms | Assigned Interventions |
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CP-945598 20 mg: Experimental |
Drug: Active treatment
20 mg CP-945598 as 15 and 5 mg tablet once daily for 3 weeks
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Placebo: Placebo Comparator |
Drug: Placebo
Placebo as two tablets once daily for three weeks
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hemoglobin ≥11 g/dL, platelet count ≥100,000 cells/mm3, neutrophil count ≥1,500cells/mm3.
Exclusion Criteria:
United States, California | |
Pfizer Investigational Site | |
Anaheim, California, United States, 92801 | |
Pfizer Investigational Site | |
Anaheim, California, United States, 92804 | |
United States, North Carolina | |
Pfizer Investigational Site | |
Durham, North Carolina, United States, 27710 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A5351053 |
Study First Received: | June 25, 2008 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00706537 |
Health Authority: | United States: Food and Drug Administration |
Pharmacokinetic safety NASH patients |
Hepatitis Liver Diseases Non-alcoholic steatohepatitis (NASH) Digestive System Diseases Fatty Liver |