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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Other forms than NASH liver disease.

• Decompensated or severe liver disease.