NCT01372163终止1 期
A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Ascending Doses Of PF-05190457 In Healthy And Type 2 Diabetic Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse Events as a measure of safety and tolerability.
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of multiple doses to healthy volunteers and Type 2 diabetic patients and to evaluate the plasma drug concentrations after multiple doses.
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 males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 30.5 kg/m^2, and weight between 50 and 100 kg, inclusive.
- •Type 2 diabetic males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 40.0 kg/m^2, weight between 50 and 150 kg, and HbA1c of 7.0-10.0%, inclusive.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- •Additionally, type 2 diabetic patients who have history of diabetic complications with significant end-organ damage or pharmacologic treatment for diabetes in addition to metformin.
研究组 & 干预措施
2 mg PF-05190457 or Placebo BID
Experimental
干预措施: PF-05190457 or Placebo (Drug)
5 mg PF-05190457 or Placebo QD
Experimental
Dose and dose frequency may be adjusted based on emerging safety and PK data.
干预措施: PF-05190457 or Placebo (Drug)
10 mg PF-05190457 or Placebo BID
Experimental
干预措施: PF-05190457 or Placebo (Drug)
40 mg PF-05190457 or Placebo BID
Experimental
Dose and dose frequency may be adjusted based on emerging safety and PK data.
干预措施: PF-05190457 or Placebo (Drug)
150 mg PF-05190457 or Placebo BID
Experimental
Dose and dose frequency may be adjusted based on emerging safety and PK data.
干预措施: PF-05190457 or Placebo (Drug)
50 mg PF-05190457 or Placebo QD
Experimental
Dose and dose frequency may be adjusted based on emerging safety and PK data.
干预措施: PF-05190457 or Placebo (Drug)
xxx mg PF-05190457 or Placebo
Experimental
Dose and dose frequency to be determined based on emerging safety and PK data.
干预措施: PF-05190457 or Placebo (Drug)
结局指标
主要结局
Number of participants with Adverse Events as a measure of safety and tolerability.
时间窗: 8 weeks
次要结局
- The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Area Under the Curve (AUC) and its accumulation ratio on days 1, 13, and 14, as appropriate and the data permit.(2 weeks)
- The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Maximum Concentration (Cmax) on days 1, 13, and 14, as appropriate and the data permit.(2 weeks)
- The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Time of Maximum concentration (Tmax) on days 1, 13, and 14, as appropriate and the data permit.(2 weeks)
- The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of the Minimum Amount of concentration (Cmin) on days 13 and 14, as appropriate and the data permit.(2 weeks)
- The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Elimination of half-life (t ½ ) on day 14, as the data permit.(2 weeks)
- The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of apparent total clearance of the drug from plasma after oral administration (CL/F) on days 13 and 14, as the data permit.(2 weeks)
- The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F) on days 13 and 14, as the data permit.(2 weeks)
- Urinary recovery and renal clearance of PF-05190457 will be estimated via comparison of the plasma AUC and urinary excretion to provide AE0-τ, AE0-τ%, and CLR as the data permit.(2 weeks)
研究者
研究点 (1)
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