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

Purpose

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	Intervention	Phase
Non-Alcoholic Steatohepatitis(NASH)	Drug: Active treatment Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, 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)

Further study details as provided by Pfizer:

Primary Outcome Measures:

Urine 6-β-hydroxycortisol:cortisol ratio [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Adverse event monitoring, physical examinations, sitting vital sign measurements (blood pressure and pulse rate), 12-lead ECGs, laboratory safety assessments. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
PK for CP-945598 and its primary circulating metabolite [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Breath ID® tests (methacetin and octanoate) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Soluble and exploratory biomarkers [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment:	9
Study Start Date:	July 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706537

Locations

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

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00706537 History of Changes
Other Study ID Numbers:	A5351053
Study First Received:	June 25, 2008
Last Updated:	August 11, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Pharmacokinetic safety NASH patients

Additional relevant MeSH terms:

Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013