A Phase 1, Randomized, Subject- And Investigator Blind, Sponsor Open, Placebo Controlled, Single- And Multiple-Dose Escalation Study Of PF-04171327 In Healthy Adult Japanese And Western Subjects In Fasting And Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Plasma pharmacokinetic parameters for PF-00251802: Cmax for Day 1 and Day 12
研究概览
简要总结
This Phase 1 study is the first clinical trial in Japanese subjects. This study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-04171327 oral tablet in healthy adult Japanese and Western subjects in fasting and fed conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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 subjects of non childbearing potential between the ages of 18 and 55 years.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- •Japanese subjects who have four Japanese grandparents born in Japan.
排除标准
- •Confirmed fasting glucose more than 100 mg/dL at Screening and Day 0 in both Cohort A and B.
- •Corticosteroid use of more than 5 mg prednisone equivalent per day for more than 6 weeks.
- •Evidence or history of clinically significant hematological (including anemia), 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).
研究组 & 干预措施
Single dose
干预措施: PF-04171327 (Drug)
Single dose
干预措施: Placebo (Drug)
Multiple dose
干预措施: PF-04171327 (Drug)
Multiple dose
干预措施: Placebo (Drug)
结局指标
主要结局
Plasma pharmacokinetic parameters for PF-00251802: Cmax for Day 1 and Day 12
时间窗: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802 : Cmax
时间窗: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802 : Tmax
时间窗: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF00251802 : AUC(0-last)
时间窗: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802 : As data permit AUC(0-inf)
时间窗: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802 : As data permit t1/2
时间窗: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax
时间窗: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax
时间窗: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUC(0-last)
时间窗: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit AUC(0-inf)
时间窗: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2
时间窗: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802: Tmax for Day 1 and Day 12
时间窗: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: AUCtau for Day 1 and Day 12
时间窗: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: As data permit t1/2 for Day12
时间窗: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12
时间窗: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: Ctrough
时间窗: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax for Day 1 and Day 12
时间窗: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax for Day 1 and Day 12
时间窗: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUCtau for Day 1 and Day 12
时间窗: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2 for Day12
时间窗: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12
时间窗: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Ctrough
时间窗: Day 1 to Day 15 in Cohort B
次要结局
- Biomarkers for bone effects: Serum procollagen type 1 N-terminal propeptide (P1NP), serum C terminal telopeptide of type I collagen (CTX), serum osteocalcin and urine N terminal telopeptide of type I collagen (uNTX).(Day 0 to Day 15 in Cohort B)
- Biomarkers for carbohydrate and metabolic: Plasma cortisol, serum glucose, plasma insulin and serum adiponectin.(Day 0 to Day 15 in Cohort B)