A Phase 1, Randomized, Subject- And Investigator-blind, Sponsor-open, Placebo-controlled, Single- And Multiple-dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Cp-601,927 In Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Suicidality assessment after single dose of 1 mg CP-601,927
研究概览
简要总结
This Phase 1 study is the first clinical trial to be conducted in Japanese subjects. The pharmacokinetics, safety and tolerability of single and multiple doses of CP-601,927 will be evaluated in Japanese, healthy, non-smoking subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female Japanese subjects between the ages of 18 and 55 years, inclusive.
- •Japanese defined as being able to document that all 4 grandparents were Japanese and were born in Japan.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Females of childbearing potential.
- •Subjects with regular (daily or weekly) use of tobacco products or nicotine currently or within the past 6 months. Subjects with urine cotinine concentrations >100 ng/mL at any time during the study will be excluded.
研究组 & 干预措施
Single dosing
Single doses of CP-601,927 (1, 2 or 3 mg) or placebo
干预措施: CP-601,927 (Drug)
Single dosing
Single doses of CP-601,927 (1, 2 or 3 mg) or placebo
干预措施: Placebo (Drug)
Multiple dosing
Multiple doses of CP-601,927 (2 mg BID, 4mg/day) or placebo
干预措施: CP-601,927 (Drug)
Multiple dosing
Multiple doses of CP-601,927 (2 mg BID, 4mg/day) or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Suicidality assessment after single dose of 1 mg CP-601,927
时间窗: Day 0, 0 and 2 hours post-dose
Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 1 mg CP-601,927
时间窗: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 2 mg CP-601,927
时间窗: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 3 mg CP-601,927
时间窗: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Ctrough, Cmax, AUC0-12, Tmax and as data permit t1/2, CL/F and Rac (accumulation ratio) based on Cmax and AUC0-12 after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days
时间窗: Day1-7
Suicidality assessment after single dose of 2 mg CP-601,927
时间窗: Day 0, 0 and 2 hours post-dose
Suicidality assessment after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days
时间窗: Day1-7
Suicidality assessment after single dose of 3 mg CP-601,927
时间窗: Day 0, 0 and 2 hours post-dose
次要结局
未报告次要终点