NCT01992614已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Fed And Fasted Administration Of Single Escalating Oral Doses In Healthy 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
- 24
- 试验地点
- 1
- 主要终点
- Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
研究概览
简要总结
PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06678552 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, 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.
- •Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight >50 kg
- •Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL
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 time of dosing)
研究组 & 干预措施
Cohort 1
Experimental
Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
干预措施: PF-06678552 or Placebo (Drug)
Cohort 2
Experimental
Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
干预措施: PF-06678552 or Placebo (Drug)
Cohort 3
Experimental
Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
干预措施: PF-06678552 or Placebo (Drug)
结局指标
主要结局
Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
时间窗: 0 to 72 hours post dose
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927(0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06644927(0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Maximum Observed Plasma Concentration (Cmax) for PF-06644927(0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927(0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Plasma Decay Half-Life (t1/2) for PF-06644927(0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Amount of PF-06644927 excreted in the urine (Ae)(0-4, 4-12, and 12-24 hours post dose)
- Percent of PF-06678552 dose excreted in the urine as PF-06644927 (Ae%)(0-4, 4-12, and 12-24 hours post dose)
- Renal Clearance (CLr) for PF-06644927(0-4, 4-12, and 12-24 hours post dose)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06678552(0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552(0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Apparent Oral Clearance (CL/F) for PF-06678552(0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552(0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Maximum Observed Plasma Concentration (Cmax) for for PF-06678552(0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Plasma Decay Half-Life (t1/2) for PF-06678552(0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Apparent Volume of Distribution (Vz/F) for PF-06678552(0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
研究者
研究点 (1)
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