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

Phase 1

Completed

• Conditions: Non-Alcoholic Steatohepatitis(NASH)
• Interventions: Drug: Active treatment; Drug: Placebo

• Registration Number: NCT00706537
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-25
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-27
• Study Start: 2008-07
• Status Verified: 2008-11
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Disposition First Submitted: 2009-08-11
• Disposition First Submitted QC: 2009-08-11
• Last Update Submitted: 2009-08-11
• Disposition First Posted: 2009-08-13
• Last Update Posted: 2009-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CP-945598 20 mg	Active treatment	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Urine 6-β-hydroxycortisol:cortisol ratio	3 weeks
Adverse event monitoring, physical examinations, sitting vital sign measurements (blood pressure and pulse rate), 12-lead ECGs, laboratory safety assessments.	8 weeks
PK for CP-945598 and its primary circulating metabolite	6 weeks

Secondary Outcome Measures

Name	Time	Method
Breath ID® tests (methacetin and octanoate)	6 weeks
Soluble and exploratory biomarkers	3 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Durham, North Carolina, United States