NCT01490762已完成1 期
A Phase 1, Open-label, Randomized, Crossover Design Clinical Trial in Healthy Normal Volunteers to Evaluate Insulin Exposure and Effect Following Inhalation of Technosphere® Insulin Inhalation Powder at Multiple Doses Using the Gen2C Inhaler
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- area-under-the-serum insulin concentration versus time curve (AUC0-240min) for inhaled Technosphere Insulin (TI) post-dosing of a TI dose (10 U, 30 U, 60 U or 80U). Time points: 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180 and 240 minutes post-TI dosing
研究概览
简要总结
This is an open-Label, Randomized Study in Healthy Normal Volunteers looking at exposure and effects (PK/PD) of multiple doses of Technosphere® Insulin (TI) using the Gen2C inhaler.
详细描述
Healthy Normal Volunteers will be randomized to a sequence of 4 different doses of Technosphere® Insulin (TI), inhaled using the Gen2C device, and one dose of subcutaneously injected Regular Human Insulin. A euglycemic clamp procedure will be performed at each dosing visit. The purpose of this study is to determine the insulin dose proportionality/linearity of Technosphere® Insulin (TI) Inhalation Powder based on the AUCo-180 after administration of the following doses using the Gen2C inhaler:
- 10 U (one 10 U cartridge)
- 30 U (one 10 U and one 20 U cartridge)
- 60 U (three 20 U cartridges)
- 80 U (four 20 U cartridges)
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
- None
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
- •Men and women aged 18 to 55 years who are considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
- •Good venous access for blood draws
- •No smoking in the previous 6 months (including cigarettes, cigars, pipes) and negative urine cotinine testing (< 100 ng/mL)
- •Body mass index (BMI) < 32 kg/m2
- •FEV1 = 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
- •FVC = 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
- •Written informed consent provided
排除标准
- •Blood donation of 500 mL within the previous 56 days
- •Fasting blood sugar >130 mg/dL
- •History of coronary artery disease, peripheral vascular disease, or congestive heart failure
- •Allergy to study drug, food, or other study material (eg, peanuts, soy products)
- •Clinically significant active or chronic illness
- •History of asthma, COPD, or any other clinically relevant chronic lung disease
- •Respiratory tract infection within 4 weeks before screening
- •Donation of blood within 3 months before screening
- •History of drug or alcohol abuse
- •Positive urine drug screen
- •Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality
- •Any subject who, in the opinion of the PI or a designee, appears to not be qualified for this study
- •Exposure to any other investigational drug or device within 30 days before treatment or within 90 days before treatment for drugs known to modify glucose metabolism (except metformin
- •History of malignancy within the 5 years before screening (other than basal cell carcinoma)
- •History of human immunodeficiency virus (HIV) infection or hepatitis B or C
- •Women who are pregnant, lactating, or planning to become pregnant during the clinical study period
- •Any subject who at Visit 2 has a blood glucose value = 150 mg/dL 2 hours after the meal, should be discussed with the MKC medical monitor and may be removed as potentially having impaired glucose tolerance
- •Inability, in the opinion of the PI or a designee, to adequately inhale TI Inhalation Powder
- •Women of childbearing potential (defined as premenopausal and not surgically sterilized or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for the purposes of this clinical study includes experiencing amenorrhea for 2 or more years or being surgically sterile
研究组 & 干预措施
Regular Human Insulin
Active Comparator
Subcutaneous injection
干预措施: Regular Human Insulin (Drug)
TI and Regular Human Insulin
Experimental
All subjects have 4 clamp procedures with 10, 30, 60,80 units of TI and 1 clamp with 15 IU Regular Human Insulin
干预措施: Technosphere Insulin Inhalation Powder using the Gen2C inhaler (Drug)
结局指标
主要结局
area-under-the-serum insulin concentration versus time curve (AUC0-240min) for inhaled Technosphere Insulin (TI) post-dosing of a TI dose (10 U, 30 U, 60 U or 80U). Time points: 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180 and 240 minutes post-TI dosing
时间窗: crossover 4 times over the course of up to 5 weeks
次要结局
- Area-under-the-serum insulin concentration versus time curve (AUC0-240min) for inhaled Technosphere Insulin (TI) compared to that of subcutaneous regular human insulin (RHI)(crossover 5 times over the course of up to 6 weeks)
- Area-under-the-serum glucose infusion rate (GIR AUC0-240min) for TI compared to AUC0-600min for RHI(crossover 5 times over the course of up to 6 weeks)
- Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations(crossover 5 times for up to 6 weeks)
研究者
研究点 (1)
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