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)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Urine 6-β-hydroxycortisol:cortisol ratio
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Other forms than NASH liver disease.
- •Decompensated or severe liver disease.
研究组 & 干预措施
CP-945598 20 mg
干预措施: Active treatment (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Urine 6-β-hydroxycortisol:cortisol ratio
时间窗: 3 weeks
Adverse event monitoring, physical examinations, sitting vital sign measurements (blood pressure and pulse rate), 12-lead ECGs, laboratory safety assessments.
时间窗: 8 weeks
PK for CP-945598 and its primary circulating metabolite
时间窗: 6 weeks
次要结局
- Breath ID® tests (methacetin and octanoate)(6 weeks)
- Soluble and exploratory biomarkers(3 weeks)