Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH

Non-Alcoholic Steatohepatitis(NASH) Clinical Trial

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)

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fatty Liver
• Non-Alcoholic Steatohepatitis(NASH)

• NCT number: NCT00706537
• Study type: Interventional
• Source: Pfizer
• Status: Completed
• Phase: Phase 1
• Start date: July 2008
• Completion date: November 2008