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

Non-Alcoholic Steatohepatitis(NASH) Clinical Trial

Official title:

A Multiple Dose, Randomized, Double-Blind (3rd Party Open), Placebo-Controlled Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of CP-945598 In Subjects With Nonalcoholic Steatohepatitis (NASH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706537
• Other study ID #: A5351053
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2008
• Last updated: August 11, 2009
• Start date: July 2008
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fatty Liver
• Non-Alcoholic Steatohepatitis(NASH)

Intervention

Drug:
• Active treatment
20 mg CP-945598 as 15 and 5 mg tablet once daily for 3 weeks
• Placebo
Placebo as two tablets once daily for three weeks

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine 6-ß-hydroxycortisol:cortisol ratio		3 weeks	No
Primary	Adverse event monitoring, physical examinations, sitting vital sign measurements (blood pressure and pulse rate), 12-lead ECGs, laboratory safety assessments.		8 weeks	No
Primary	PK for CP-945598 and its primary circulating metabolite		6 weeks	No
Secondary	Breath ID® tests (methacetin and octanoate)		6 weeks	No
Secondary	Soluble and exploratory biomarkers		3 weeks	No

External Links

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