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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
9
20 mg CP-945598 as 15 and 5 mg tablet once daily for 3 weeks
Placebo as two tablets once daily for three weeks
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Urine 6-β-hydroxycortisol:cortisol ratio
Time frame: 3 weeks
Adverse event monitoring, physical examinations, sitting vital sign measurements (blood pressure and pulse rate), 12-lead ECGs, laboratory safety assessments.
Time frame: 8 weeks
PK for CP-945598 and its primary circulating metabolite
Time frame: 6 weeks
Breath ID® tests (methacetin and octanoate)
Time frame: 6 weeks
Soluble and exploratory biomarkers
Time frame: 3 weeks
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