A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Ascending Oral Doses Of Pf-06409577 In Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
PF-06409577 is a new compound proposed for the treatment of diabetic nephropathy. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06409577 in healthy adult 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
- 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, 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
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: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
干预措施: PF-06409577 or Placebo (Drug)
Cohort 2: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
干预措施: PF-06409577 or Placebo (Drug)
Cohort 3: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
干预措施: PF-06409577 or Placebo (Drug)
Cohort 4: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
干预措施: PF-06409577 or Placebo (Drug)
Cohort 5: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
干预措施: PF-06409577 or Placebo (Drug)
Cohort 6: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
干预措施: PF-06409577 or Placebo (Drug)
Cohort 7: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
干预措施: PF-06409577 or Placebo (Drug)
Cohort 8: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
干预措施: PF-06409577 or Placebo (Drug)
Cohort 9: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
干预措施: PF-06409577 or Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: 0-48 hours post dose
Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance
时间窗: 0-48 hours post dose
Number of Participants With Laboratory Test Values of Potential Clinical Importance
时间窗: 0-48 hours post dose
Number of Participants With Vital Signs Findings (Including Bood Pressure and Pulse Rate) of Potential Clinical Importance
时间窗: 0-48 hours post dose
Number of Participants With Echocardiogram Findings of Potential Clinical Importance
时间窗: 0-48 hours post dose
次要结局
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Plasma Decay Half-Life (t1/2) for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Apparent Oral Clearance (CL/F) for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Total amount of PF-06409577 excreted in the urine over 24 hours, expressed as percent of dose (%Ae24)(0-24 hours post dose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Renal clearance for PF-06409577(0-24 hours post dose)
- Area Under the Curve From Time Zero to Time 24 hours (AUC24) for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Total amount of PF-06409577 excreted in the urine over 24 hours (Ae24)(0-24 hours post dose)
- Maximum Observed Plasma Concentration (Cmax) for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Apparent Volume of Distribution (Vz/F) for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)