A Phase 1, Randomized, Double-blind (Sponsor-open), Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06667272 Under Fed And Fasted Conditions, In Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns
研究概览
简要总结
The current study is the first clinical trial proposed with PF-06667272. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of PF-06667272 under fed and fasted conditions, in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 males and female of non-childbearing potential;
- •Body Mass Index 17.5-30.5 kg/m2;
- •Body weight >50 kg;
排除标准
- •Evidence of 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 time of dosing)
研究组 & 干预措施
Cohort 1_Period 1_Active
Single ascending dose of PF-06667272
干预措施: PF-06667272 (Drug)
Cohort 1_Period 1_Placebo
Single dose of placebo
干预措施: Placebo (Other)
Cohort 1_Period 2_Active
Single ascending dose of PF-06667272
干预措施: PF-06667272 (Drug)
Cohort 1_Period 2_Placebo
Single dose of placebo
干预措施: Placebo (Other)
Cohort 1_Period 3_Active
Single ascending dose of PF-06667272
干预措施: PF-06667272 (Drug)
Cohort 1_Period 3_Placebo
Single dose of placebo
干预措施: Placebo (Other)
Cohrot 1_Period 4_Active
Single ascending dose of PF-06667272
干预措施: PF-06667272 (Drug)
Cohort 1_Period 4_Placebo
Single dose of placebo
干预措施: Placebo (Other)
Cohort 2_Period 1_Active
Single ascending dose of PF-06667272
干预措施: PF-06667272 (Drug)
Cohort 2_Period 1_Placebo
Single dose of placebo
干预措施: Placebo (Other)
Cohort 2_Period 2_Active
Single ascending dose of PF-06667272
干预措施: PF-06667272 (Drug)
Cohort 2_Period 2_Placebo
Single dose of placebo
干预措施: Placebo (Other)
Cohort 2_Period 3_Active
Single ascending dose of PF-06667272
干预措施: PF-06667272 (Drug)
Cohort 2_Period 3_Placebo
Single dose of placebo
干预措施: Placebo (Other)
Cohort 2_Period 4_Active
Single ascending dose of PF-06667272
干预措施: PF-06667272 (Drug)
Cohort 2_Period 4_Placebo
Single dose of placebo
干预措施: Placebo (Other)
结局指标
主要结局
Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns
时间窗: Baseline (Day 1, hour 0) up to 28 days after last dose of study medication
Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
次要结局
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06667272 and PF-06818073 (as permitted)(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose)
- Maximum Observed Plasma Concentration (Cmax) for PF-06667272 and PF-06818073(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose)
- Time to Reach Maximum Observed Concentration for PF-06667272 and PF-06818073(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose)
- Plasma Decay Half-Life (t1/2) for PF-06667272 and PF-06818073(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose)
- Apparent Total Body Clearance (CL/F) for PF-06667272(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06667272 and PF-06818073(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose)
- Apparent Volume of Distribution (Vz/F) for PF-06667272(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose)
