A Phase 1b, Single-Dose, Open-Label, Parallel, Controlled Pharmacology Trial of Inhaled Technosphere®/Insulin in Non-Diabetic Subjects With COPD Versus Matched Non-Diabetic Subjects Without COPD.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 5
- 主要终点
- To evaluate the pharmacokinetic disposition of serum insulin and serum fumaryl diketopiperazine following dosing with 30 U T/I, as measured via Area Under the Curve serum insulin and AUC 0-480 min serum FDKP
研究概览
简要总结
Trial will include 40 subjects and consists of 3 visits: Screening, Treatment and Follow up. A euglycemic clamp procedure and Technosphere®/Insulin (T/I) administration will occur at Visit 2 for both COPD and non COPD subjects.
详细描述
Trial objectives are to evaluate the impact of a defined lung disease (COPD) on pharmacokinetic parameters of insulin and fumaryl diketopiperazine (FDKP) after inhalation of Technosphere®/Insulin (T/I), the investigational medicinal product. 40 non diabetic subjects, 20 COPD and 20 age/gender/BMI-matched non COPD subjects will participate in 3 visits: Visit 1 (screening), Visit 2 (subjects will undergo a euglycemic clamp procedure and be dosed with T/I) and Visit 3 (follow up visit).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects minimum 18 and maximum 70 years of age
- •Body Mass Index (BMI) = 36 kg/m2
- •Subjects with COPD: Diagnosis of COPD (emphysema and/or chronic bronchitis),
- •smoking history =10 years, chronic cough present intermittently or daily with or without sputum and/or dyspnea upon exertion.
- •Subjects with COPD: Pulmonary Function Tests - FEV1 =50% (NHANES) III
- •Predicted; FEV1/FVC < 70 % (NHANES) III; TLC =80% of Predicted (ITS) and DLco(unc) =50% of Predicted (Miller)
- •Subjects without COPD: PFTs: FEV1 = 70% NHANES III Predicted; TLC =80% of
- •Predicted (ITS) and DLco(unc) =80% of Predicted (Miller)
排除标准
- •History of pre-diabetes or diabetes
- •Previous or current treatment with any anti-diabetic drugs
- •Serum creatinine > 2.0 mg/dL in males and > 1.8 mg/dL in females
- •Active smokers defined as having smoked their last cigarette, pipe, and/or cigar without the previous 6 months
- •Previous exposure to any inhaled insulin product or investigational medicines/devices within the previous 30 days prior to entry or participation
- •Clinically significant major organ disease
- •Female subjects of childbearing potential not practicing adequate birth control
- •Subjects with COPD: Significant improvement in pre-to post-bronchodilator spirometry (defined as an increase of 12% AND 200 mL in either FVC or FEV1);
- •Any clinically important pulmonary disease except mild or moderate COPD
- •Subjects without COPD: Any important pulmonary disease confirmed by pulmonary function testing and/or radiologic findings
研究组 & 干预措施
Non-Diabetic Subj. w/o COPD
Single dose, 30 units
干预措施: Technosphere®/Insulin (Drug)
Non-Diabetic Subj. with COPD
Single dose, 30 units
干预措施: Technosphere®/Insulin (Drug)
结局指标
主要结局
To evaluate the pharmacokinetic disposition of serum insulin and serum fumaryl diketopiperazine following dosing with 30 U T/I, as measured via Area Under the Curve serum insulin and AUC 0-480 min serum FDKP
时间窗: 30 days
次要结局
- Efficacy endpoints include: additional PK parameters of serum insulin and serum FDKP, Pharmacodynamic parameters of sersum insulin, safety of T/I(30 days)