NCT03232905已完成1 期
A Phase 1, Randomized, Double-blind, Third-party Open, Placebo-controlled Study To Evaluate The Safety, Tolerability, And Pharmacokinetics After Multiple Oral Doses Of Pf-06651600 In Healthy Japanese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs
研究概览
简要总结
This study is a phase 1 study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 after multiple oral doses of PF-06651600 in Japanese healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subject must have four Japanese grandparents who were born in Japan.
- •Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
- •No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- •BMI of 17.5 to 27.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •Evidence of personally signed and dated informed consent document.
- •Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- •Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
- •Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
- •History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
- •Screening blood pressure >140/90 mm Hg.
- •Screening laboratory abnormalities as defined by the protocol.
- •Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.
研究组 & 干预措施
Placebo
Placebo Comparator
Multiple ascending doses of Placebo
干预措施: Placebo (Drug)
PF-06651600
Experimental
Multiple ascending doses of PF-06651600
干预措施: PF-06651600 (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs
时间窗: Baseline up to Day 45
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS interval, QT Interval, QTC Interval, heart rate)
时间窗: Baseline, 1 hour post-dose on Day 1 and 10
Number of Participants With Change From Baseline in Physical Examinations
时间窗: Baseline up to Day 28
Number of Participants With Laboratory Abnormalities
时间窗: Baseline up to Day 28
Change From Baseline in Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature)
时间窗: Baseline, Day 1, 10, 12 and 28
次要结局
- Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 1(pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1)
- Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 10(pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 1(pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 10(pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10)
- Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06651600 at Day 1(pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06651600 at Day 1(pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1)
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 1(pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1)
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 10(pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10)
- Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 1(pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1)
- Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 10(pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10)
- Observed Accumulation Ratio (Rac) on AUCtau for PF-06651600 at Day 10(pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10)
- Observed Accumulation Ratio on Cmax (RacCmax) for PF-06651600 at Day 10(pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10)
- MinimumObserved Plasma Concentration (Cmin) of PF-06651600 at Day 10(pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10)
研究者
研究点 (1)
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