NCT02287272已完成1 期
Open-label, Randomized, Single Dose, 2-sequence, 2-period Cross-over Study to Investigate the Effect of Inhibition of the Organic Cation Transport in the Kidneys by Cimetidine on the Pharmacokinetics of the CHF5993 in Healthy Volunteers
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
- 25
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) of Glycopyrronium Bromide
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic interaction when CHF5993 (pressurized metered-dose inhaler (pMDI) is administered with Cimetidine (probe inhibitor of the organic cation transport in the kidneys), by comparing the systemic exposure (AUC0-t) of Glycopyrronium Bromide (GB), after a single dose of the fixed combination CHF 5993 pMDI administered alone or at steady-state of Cimetidine
详细描述
the safety and tolerability of study treatments based on evaluation of vital signs, electrocardiograms and clinical laboratory assessments will be also evaluated.
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 45 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;
- •Male and female healthy volunteers aged 18-45 years inclusive;
- •Male subjects with female partner of childbearing potential: they or their partner must be willing to use (at least) one or more reliable methods of contraception (see exclusion criterion n.1 for details*) from the time of dose administration and until the end of the study. Male subjects must not donate sperm for 90 days after the last dose of study drug. Male subjects with partners of non-childbearing potential are not required to use contraception;
- •Able to understand the study procedures, the risks involved and ability to be trained to correctly use the devices;
- •Body Mass Index (BMI) between 18.0 and 30.0 kg/m2 inclusive;
- •A serum creatinine within the normal range (0,7-1,2 mg/dL) and an eGFR >80 mL/min/1.73 m2;
- •Non- or ex-smokers who smoked < 5 pack years (pack-years = the number of cigarette packs per day times the number of years) and stopped smoking > 1 year;
- •Good physical and mental status, determined on the basis of the medical history and a general clinical examination;
排除标准
- •Female subjects: pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) documented amenorrhea or are willing to use one or more of the following reliable *methods of contraception:
- •surgical sterilization (e.g. bilateral tubal ligation, hysterectomy for females; vasectomy for males)
- •hormonal contraception (implantable, patch, oral), intrauterine device (IUD) or intrauterine system (IUS)
- •barrier methods (male or female condom, diaphragm, sponge, cervical cap).
- •Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication;
- •Positive HIV1 or HIV2 serology;
- •Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C;
- •History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening;
- •An abnormal triplicate 12-lead ECG (QRS> 120 msec, PR> 220 msec, HR < 40 bpm, HR > 110 bpm) at screening or at randomization;
- •Subjects whose electrocardiogram (12-lead ECG) shows QTcF >450 ms for males and >470 for females at screening or at randomization;
- •Subjects whose DBP is higher than 90 mmHg or SBP is higher than 140 mmHg at screening or at randomization;
- •Subjects who received any investigational new drug, or participated in clinical study within the last 8 weeks before screening;
- •History of hypersensitivity to M3 Antagonists, β2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial;
- •Treatment within the previous 3 months before the screening visit until the end of the study procedures in the last treatment period with any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole);
- •Subjects who refuse to abstain from alcohol or xanthine containing foods or beverages or grapefruit containing foods or beverages from 48 hour prior to each intake of study medication until the end of confinement at the clinical centre;
- •Heavy caffeine drinker (> 5 cups or glasses of caffeinated beverages e.g., coffee, tea, cola per day);
- •Subjects who have a positive urine test for cotinine at screening.
研究组 & 干预措施
Treatment period R
Active Comparator
single inhaled dose of CHF 5993 pMDI (BDP/FF/GB fixed dose combination)
干预措施: CHF 5993 pMDI (Drug)
Treatment period T
Active Comparator
Cimetidine plus CHF5993 pMDI: repeated doses of oral cimetidine for 6 days plus a single inhaled dose of CHF 5993 pMDI (BDP/FF/GB fixed dose combination)
干预措施: Cimetidine plus CHF5993 pMDI (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) of Glycopyrronium Bromide
时间窗: pre-dose, 5, 10,15,30min, 1,2,4,6,8,12hr post-dose
次要结局
- Other pharmacokinetic parameters for B17MP(pre-dose- 72hr post-dose)
- Other pharmacokinetic parameters for Formoterol(pre-dose-24hr post dose)
- Other pharmacokinetic parameters for Glycopyrronium Bromide(pre-dose-72hr post-dose)
研究者
研究点 (1)
Loading locations...
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