A Phase 1, Open-label, Randomized, Crossover Clinical Trial to Evaluate PK/PD of 30 U TI Inhalation Powders Prepared With Insulin From Two Different Suppliers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- AUC (area-under-the-serum-insulin concentration time curve) 0 - 240 minutes
研究概览
简要总结
A Phase 1, open-label randomized crossover trial in Healthy Volunteers to evaluate the PK/PD of TI (Technosphere® Insulin) prepared with insulin from two different suppliers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
- •HNVs with a screening blood pressure less than 140/90 mm Hg
- •Subjects who have hypertension controlled with up to 1 medication and who have a blood pressure less than 140/90 mm Hg
- •Note: For subjects with blood pressure at or above 140/90 mm Hg; two additional readings 5 minutes apart are allowed but the last blood pressure reading must be in range
- •Subjects who have hypercholesterolemia controlled with up to 1 medication and who have a low-density lipoprotein value less than 160 mg/dL
- •Good venous access for blood draws
- •No smoking in the past 6 months (including cigarettes, cigars, and pipes) and urine cotinine testing < 100 ng/mL
- •Body mass index (BMI) < 32 kg/m2
- •Completion of informed consent form
排除标准
- •Blood donation (500 mL) within the last 8 weeks
- •Fasting blood sugar >100 mg/dL
- •History of coronary artery disease, peripheral vascular disease, or congestive heart failure
- •Allergy to study drug, components of Boost and Boost Plus, or other study material
- •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
- •History of drug or alcohol abuse within the past 5 years
- •Positive urine drug screen
- •Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality
- •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
- •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
- •Women of childbearing potential (premenopausal who have not undergone hysterectomy or bilateral tubal ligation, 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.
- •Any subject who, in the opinion of the PI or a designee, appears not to be qualified for this study
研究组 & 干预措施
Sequence (Group) 1
Subjects randomized to Sequence 1 will receive TI in the following sequence:
TI-Inhalation Powder A TI-Inhalation Powder B
*30 units (10 units + 20 units)
干预措施: TI-Inhalation Powder A (Drug)
Sequence (Group) 1
Subjects randomized to Sequence 1 will receive TI in the following sequence:
TI-Inhalation Powder A TI-Inhalation Powder B
*30 units (10 units + 20 units)
干预措施: TI-Inhalation Powder B (Drug)
Sequence (Group) 2
Subjects randomized to Sequence 2 will receive TI in the following sequence:
TI-Inhalation Powder B TI-Inhalation Powder A
*30 units (10 units + 20 units)
干预措施: TI-Inhalation Powder A (Drug)
Sequence (Group) 2
Subjects randomized to Sequence 2 will receive TI in the following sequence:
TI-Inhalation Powder B TI-Inhalation Powder A
*30 units (10 units + 20 units)
干预措施: TI-Inhalation Powder B (Drug)
结局指标
主要结局
AUC (area-under-the-serum-insulin concentration time curve) 0 - 240 minutes
时间窗: 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240
Cmax (maximum serum insulin concentration)
时间窗: 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240
次要结局
- GIR (area-under-the-serum Glucose Infusion Rate)(0 to 360)