A 2-week, Phase 1b, Randomized, Double-Blind, Placebo- Controlled, Multi-Dose, Dose-Escalating Study With PF-03882845 And One Dose Of Spironolactone To Evaluate Safety, Tolerability, Pharmacokinetics And Pharmacodynamics In Subjects With Type 2 Diabetes Mellitus And Albuminuria
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change From Baseline in Serum Potassium at Day 8
研究概览
简要总结
PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-03882845 in this population.
详细描述
This study was terminated on 12-Sep-2012; this decision was made due to poor recruitment and overall business strategy. The study was not terminated for safety reasons nor for lack of efficacy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and/or Females between 18-65 years, inclusive.
- •Body mass index of 18.5 to 45.4 kg/m2 at screening, inclusive. body weight equals or greater than 110 lb.
- •Have type 2 diabetes mellitus.
- •On stable dose of anti-diabetic and anti-hypertensive medication prior to screening.
排除标准
- •Recent evidence or medical history of unstable concurrent disease.
- •Cardiovascular event within 3 months prior to screening.
- •History of renal transplant.
- •History of hospitalization for acute kidney injury or acute kidney dialysis within 6 months prior to screening.
研究组 & 干预措施
PF03882845
干预措施: PF-03882845 (Drug)
Spironolactone
25 mg once daily
干预措施: Spironolactone (Drug)
Placebo
Placebo once daily
干预措施: placebo (Other)
结局指标
主要结局
Change From Baseline in Serum Potassium at Day 8
时间窗: Baseline, Day 7, 8
Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 8 value calculated was average of 0 hours (immediately pre-dose) measurements on Day 7 and 8. Change from baseline values were presented under time point of Day 8.
Change From Baseline in Serum Potassium at Day 15
时间窗: Baseline, Day 14, 15
Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 15 value calculated was average of 0 hours (immediately pre-dose) measurement on Day 14 and measurement obtained prior to discharge on Day 15. Change from baseline values were presented under time point of Day 15.
Number of Participants With Confirmed and Severe Hyperkalemia
时间窗: Baseline up to Day 15
Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. Confirmed hyperkalemia is defined as serum potassium level greater than (\>) upper limit of normal (ULN) of 5.4 mEq/L. Severe hyperkalemia is defined as serum potassium level \>= 6.0 mEq/L. Number of participants with at least 1 confirmed or severe hyperkalemia is reported.
次要结局
- Plasma Pharmacokinetic (PK) Parameters(0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14)
- Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15(Day 1 (Baseline), 15)
- Change From Baseline in Sitting Pulse Rate at Day 15(Day 1 (Baseline), 15)