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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00706537
First received: June 25, 2008
Last updated: August 11, 2009
Last verified: November 2008
History of Changes

June 25, 2008
August 11, 2009
July 2008
November 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00706537 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH
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)

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Non-Alcoholic Steatohepatitis(NASH)
  • Drug: Active treatment
    20 mg CP-945598 as 15 and 5 mg tablet once daily for 3 weeks
  • Drug: Placebo
    Placebo as two tablets once daily for three weeks
  • Experimental: CP-945598 20 mg
    Intervention: Drug: Active treatment
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00706537
A5351053
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP