Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH
Summary
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.
Study Design
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Conditions
Non-Alcoholic Steatohepatitis(NASH)
Intervention
Active treatment, Placebo
Location
Pfizer Investigational Site
Anaheim
California
United States
92801
Status
Completed
Source
Pfizer
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00706537
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Liver Diseases, Alcoholic
Liver diseases associated with ALCOHOLISM. It usually refers to the coexistence of two or more subentities, i.e., ALCOHOLIC FATTY LIVER; ALCOHOLIC HEPATITIS; and ALCOHOLIC CIRRHOSIS.
Alcoholic Intoxication
An acute brain syndrome which results from the excessive ingestion of ETHANOL or ALCOHOLIC BEVERAGES.
Fatty Liver, Alcoholic
Lipid infiltration of the hepatic parenchymal cells that is due to ALCOHOL ABUSE. The fatty changes in the alcoholic fatty liver may be reversible, depending on the amounts of TRIGLYCERIDES accumulated.
Pancreatitis, Alcoholic
Acute or chronic INFLAMMATION of the PANCREAS due to excessive ALCOHOL DRINKING. Alcoholic pancreatitis usually presents as an acute episode but it is a chronic progressive disease in alcoholics.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
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PubMed Articles
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