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

Completed · Phase 1 · Has a placebo group

Conditions studied: Non-Alcoholic Steatohepatitis(NASH)

In brief

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.

Key facts

Study ID

NCT00706537

Run by

Pfizer

People needed

9

Starts

2008-07-01

Expected to finish

2008-11-01

Last updated by the study team

2009-08-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body Mass Index (BMI) of 25 to 40 kg/m2
• Subjects with biopsy evidence of NASH in the 2 years prior to the screening visit.
• Hemoglobin ≥11 g/dL, platelet count ≥100,000 cells/mm3, neutrophil count ≥1,500cells/mm3.

You may not qualify if…

• Other forms than NASH liver disease.
• Decompensated or severe liver disease.

Where it is running

• Pfizer Investigational Site — Anaheim, California, United States
• Pfizer Investigational Site — Anaheim, California, United States
• Pfizer Investigational Site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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