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

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NCT00706537

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Study Location
Pfizer Investigational Site
Anaheim, California, 92801, United States
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Contact
1-800-718-1021
[email protected]
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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Alcoholic Steatohepatitis(NASH)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Other forms than NASH liver disease.


- Decompensated or severe liver disease.

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Non-Alcoholic Steatohepatitis(NASH)Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH NCT00706537
  1. Anaheim, California
  2. Anaheim, California
  3. Durham, North Carolina
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Non-Alcoholic Steatohepatitis(NASH)
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: CP-945598 20 mg
    Intervention: Drug: Active treatment
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2008)		9
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2008)		20
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00706537
Other Study ID Numbers  ICMJE A5351053
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2008

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