ACTRN12621000718842
已完成
1 期
A Phase 1, Open-Label, Randomized, Single Dose Study of Flecainide Acetate Inhalation Solution (FlecIH-103) to Flecainide Acetate Intravenous Infusion (Tambocor®) to Compare Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Atrial Fibrillation
- 发起方
- InCarda Therapeutics Australia Pty Ltd.
- 入组人数
- 19
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Be males or females, 18 to 55 years of age (inclusive), with body mass index (BMI) between 20 and 32 kg/m2 (inclusive) and a body weight (BW) greater than or equal to 70 kg, no significant medical history, and in good general health as determined by the PI or delegate at the clinical facility.
- •Be non\-smokers or former smokers who have not consumed tobacco, e\-cigarettes and/or marijuana products within 6 months of Day 1 AND have a less than or equal to 5 pack year previous history. Light smokers who have consumed less than or equal to 5 cigarettes per week within 6 months of Day 1 AND who do not have a 5 pack per year previous history are eligible, but must abstain from smoking for 30 days prior to Day 1\. All participants must pass a cotinine urine test to be enrolled.
- •Have no evidence of asthma, chronic obstructive pulmonary disease (COPD) or major pulmonary airway disease, including participants with established pulmonary disease in need of inhalation medication (participants with history of childhood asthma but no subsequent episodes are eligible).
- •Have no history of heart disease, including but not limited to, coronary artery disease, myocardial infarction, heart failure of any cause, clinically significant cardiac arrhythmias and valvular heart disease.
- •Have no previous invasive cardiac procedures (participants having undergone invasive cardiac procedures which definitively demonstrated no cardiac issues are eligible).
- •Have no clinically significant family history of cardiac arrhythmias, acquired or congenital.
- •Have not participated in any other investigational study within 30 days prior to dose administration or within 5 half\-lives of the experimental drug (whichever is longer).
- •Have to meet a number of specific cardiovascular (measured with a 12\-lead ECG) and hemodynamic parameters, as follows:
- •Heart Rate (HR) greater than 47 bpm
- •PR Interval less than or equal to 190 ms
排除标准
- •1\. Evidence of asthma, chronic obstructive pulmonary disease (COPD) or major pulmonary airway disease, including participants with established pulmonary disease in need of inhalation medication; (participants with history of childhood asthma but no subsequent episodes are eligible)
- •2\. Evidence of early repolarization pattern in the ECG, defined as elevated J\-Point or end\-QRS slurring with or without concave ST\-segment elevation \[MacFarlane, 2015]. A J\-Point elevation of greater than or equal to 0\.1 mV and prominent end\-QRS notch or slur in 2 contiguous ECG leads should be flagged for review by the study cardiologist and/or medical monitor. Minor findings are considered acceptable.
- •3\. History of heart disease such as, coronary artery disease, MI, cardiac arrhythmias, valvular heart disease and heart failure.
- •4\. Previous invasive cardiac procedures (participants having undergone invasive cardiac procedures which definitively demonstrated no cardiac issues are eligible);
- •5\. Clinically significant family history of cardiac arrhythmias, acquired or congenital (e.g., Brugada and/or long\-QT syndromes), unexplained sudden cardiac death, and/or unexplained syncope
- •6\. Family history of congenital airway lung obstructive disease
- •7\. Use of prescription medication or over\-the\-counter products (including other antiarrhythmic drugs, anticoagulants and BP lowering drugs, medications known to prolong the QTc interval, natural food supplements, vitamins, and garlic as a supplement) within 7 days prior to administration of study treatment, except for topical products without systemic absorption, paracetamol, and/or protocol\-compliant contraceptives
- •8\. Any contraindications to flecainide as per Tambocor package insert
- •9\. Has experienced any symptomatic heart failure (per New York Heart Association \[NYHA] guidelines), or history of impaired LVEF.
- •10\. Has human immunodeficiency virus infection, as shown by the presence of anti\-human immunodeficiency virus (HIV) antibody (sero\-positive).
结局指标
主要结局
未指定
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