A Phase 1b, Single-Dose, Open Label, Parallel Design, Controlled Pharmacology Trial of Fumaryl Diketopiperazine Administered as Technosphere Inhalation Power in Subjects With Either Mild or Moderate Chronic Kidney Disease vs. Matched Subjects Without Chronic Kidney Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Differences in exposure to fumaryl diketopiperazine (FDKP)
研究概览
简要总结
24 diabetics with mild & moderate renal disease and 12 diabetics without renal disease. One screening, one dosing & one follow-up visit with Technosphere® Inhalation Powder given at Visit 2 via MedTone® Inhaler and PK testing at 26 designated time points
详细描述
This Phase 1, single-dose trial is being conducted to determine if nephropathy affects the way the kidneys eliminate the byproducts of Technosphere® Inhalation Powder as compared to kidneys free of disease. This trial will test the safety, tolerability and pharmacokinetics of the study medication. The trial consists of a screening, dosing and a follow-up visit. Single dose administration of Technosphere® Inhalation Powder occurs at the dosing visit. (V2) with serum and urine PK testing .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-smoking males and females, = 18 and = 80 years with a BMI of = 37 kg/m2
- •Type 1 or type 2 diabetic
- •Subjects with mild or moderate DNP and subjects with normal renal function, based on GFR rate and albuminuria
- •Normal pulmonary function and performance based on PFTs
排除标准
- •No history of COPD, asthma, or active respiratory infection; must be able to perform PFTs
- •No dose and/or formulation changes within the preceding 6 weeks for any concomitant medications
- •No clinically significant major organ/systemic disease
- •No previous or current chemotherapy or radiation therapy that may result in pulmonary toxicity
- •No clinically significant abnormalities on screening laboratory evaluation, except abnormal laboratory renal parameters in subjects with DNP
研究组 & 干预措施
T Inhalation powder in diabetic subjs w/ normal renal func
T inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units
干预措施: Technosphere Inhalation Powder (Drug)
T Inhalation powder diabetic subj w/mild or moderate nephrop
T Inhalation powder in diabetic subjects w/mild or moderate nephropathy - Single dose, 30 units
干预措施: Technosphere Inhalation Powder (Drug)
结局指标
主要结局
Differences in exposure to fumaryl diketopiperazine (FDKP)
时间窗: 14 days
次要结局
- Additional safety parameters(14 days)