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Sponsored by: |
Pfizer |
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 |
Non Alcoholic Steato Hepatitis (NASH) |
Drug: Active treatment Drug: Placebo |
Phase I |
MedlinePlus related topics: | Hepatitis |
Drug Information available for: | CP 945598 |
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) |
Estimated Enrollment: | 20 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | October 2008 |
Arms | Assigned Interventions |
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:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, California | |||||
Pfizer Investigational Site | Recruiting | ||||
Anaheim, California, United States, 92801 | |||||
Pfizer Investigational Site | Recruiting | ||||
Anaheim, California, United States, 92804 | |||||
United States, North Carolina | |||||
Pfizer Investigational Site | Recruiting | ||||
Durham, North Carolina, United States, 27710 |
Pfizer |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
To obtain contact information for a study center near you, click here. 
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Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A5351053 |
First Received: | June 25, 2008 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00706537 |
Health Authority: | United States: Food and Drug Administration |
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