OPEN-LABEL, RANDOMIZED, 2-WAY CROSS-OVER, SINGLE DOSE STUDY IN HEALTHY VOLUNTEERS TO INVESTIGATE THE PHARMACOKINETICS OF CHF 6001 DPI ADMINISTERED USING THE MULTI-DOSE RESERVOIR NEXThaler® DEVICE OR THE CAPSULE FOR ORAL INHALATION VIA AEROLIZER® DEVICE
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration-time curve of CHF 6001
研究概览
简要总结
The purpose of this study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 administered using the multi-dose NEXThaler® device or the single-dose capsule inhaler Aerolizer®.
CHF 6001 is an antinflammatory drug under development for Chronic obstructive pulmonary disease (COPD) therapy. The drug is presented as dry powder for inhalation delivered by an inhaler device. Previous studies were conducted using a single-dose capsule inhaler (Aerolizer®) device. For the subsequent clinical studies a novel multi-dose NEXThaler® device will be used.
详细描述
This is an Open-label, randomized, 2-way cross-over, Phase I study. The study is conducted in 1 single european site. The main scope of the study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 DPI administered using the multi-dose reservoir NEXThaler® device or the single-dose capsule Aerolizer® device.
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
- •Subject's written informed consent obtained prior to any study-related procedure
- •Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly
- •Able to generate sufficient PIF
- •Male and female subjects aged 18 to 55 years inclusive
- •Body mass index (BMI) within the range of 18 to 30 kg/m2 inclusive
- •Non- or ex-smokers who smoked < 5 pack years
- •Good physical and mental status
- •Lung function within normal limits
- •Results of laboratory tests within the normal ranges
- •adequate contraception
排除标准
- •Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication
- •Pregnant or lactating women
- •Positive HIV1 or HIV2 serology
- •Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C
- •Unsuitable veins for repeated venipuncture
- •History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen
- •Subjects who have a positive urine test for cotinine at screening or at randomization
- •Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation
- •Clinically relevant and uncontrolled hepatic, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
- •Subjects who have clinically significant cardiovascular condition according to investigator's judgment
- •An abnormal 12-lead ECG
- •Subjects whose electrocardiogram (12-lead ECG) shows QTcF > 450 ms for males or QTcF > 470 ms for females
- •Diastolic Blood Pressure > 90 mmHg and/or Systolic Blood Pressure > 140 mmHg
- •Participation in another clinical trial where investigation drug was received less than 8 weeks prior to screening
- •History of hypersensitivity to any of the excipients contained in the formulations used in the trial
- •Any drug treatment, including prescribed or OTC medicines as well as vitamins, homeopathic remedies etc, taken in the 14 days (2 months for enzyme-inducing or enzyme-inhibiting drugs e.g., glucocorticoids, phenobarbital) before the screening visit and likely to receive these treatments until the end of the study procedures with the exception of occasional paracetamol (maximum 2 g per day with a maximum of 10 g per 14 days for mild non-excluding conditions), hormonal contraceptives and hormonal replacement treatment for post-menopausal women
- •Treatment within the previous 3 months before the screening visit and likely to receive these treatments until the end of the study procedures in the last treatment period with biologic drugs and with any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole)
- •Subjects who refuse to respect the required study restrictions related to alcohol, xanthine, grapefruit, food and water intake and strenuous activities
- •Heavy caffeine drinker
结局指标
主要结局
Area under the plasma concentration-time curve of CHF 6001
时间窗: 30 min and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours after study drug administration at Period 1 and Period 2
CHF 6001 AUC0-t (area under the plasma concentration-time curve from time 0 to the last quantifiable concentration) and Cmax (maximum plasma concentration).
次要结局
- Other pharmacokinetic parameters for CHF 6001 and metabolites in plasma(pre-dose, 30 min and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours after study drug administration at period 1 and 2)