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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Non-Alcoholic Steatohepatitis(NASH)

Treatments: Drug: Active treatment; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00706537

A5351053

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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9 participants in 2 patient groups, including a placebo group

CP-945598 20 mg

Experimental group

Treatment:

Drug: Active treatment

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo