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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00706537
Recruitment Status : Completed
First Posted : June 27, 2008
Last Update Posted : August 13, 2009
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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.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Steatohepatitis(NASH) Drug: Active treatment Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
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)
Study Start Date : July 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CP-945598 20 mg Drug: Active treatment
20 mg CP-945598 as 15 and 5 mg tablet once daily for 3 weeks

Placebo Comparator: Placebo Drug: Placebo
Placebo as two tablets once daily for three weeks

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

Secondary Outcome Measures :
  1. Breath ID® tests (methacetin and octanoate) [ Time Frame: 6 weeks ]
  2. Soluble and exploratory biomarkers [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00706537

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United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
Pfizer Investigational Site
Anaheim, California, United States, 92804
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00706537    
Other Study ID Numbers: A5351053
First Posted: June 27, 2008    Key Record Dates
Last Update Posted: August 13, 2009
Last Verified: November 2008
Keywords provided by Pfizer:
Pharmacokinetic safety NASH patients
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases