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

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NCT00706537

Last updated on May 11, 2018
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FOR MORE INFORMATION
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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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.

NCT00706537
Pfizer
Completed
Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH

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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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00706537
A5351053
No
Not Provided
Not Provided
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

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