Non-Alcoholic Steatohepatitis(NASH) Clinical Trial
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)
Verified date | November 2008 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | November 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | Anaheim | California |
United States | Pfizer Investigational Site | Anaheim | California |
United States | Pfizer Investigational Site | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urine 6-ß-hydroxycortisol:cortisol ratio | 3 weeks | No | |
Primary | Adverse event monitoring, physical examinations, sitting vital sign measurements (blood pressure and pulse rate), 12-lead ECGs, laboratory safety assessments. | 8 weeks | No | |
Primary | PK for CP-945598 and its primary circulating metabolite | 6 weeks | No | |
Secondary | Breath ID® tests (methacetin and octanoate) | 6 weeks | No | |
Secondary | Soluble and exploratory biomarkers | 3 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03025074 -
Blood Collection Biorepository for Liver Disease Research
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