ACTRN12613000971730已完成不适用
A Phase 1, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Two Different Intranasal Formulations of MSP-2017 in Healthy Adult Male Subjects.
CPR Pharma Services0 个研究点目标入组 48 人开始时间: 2013年9月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 19 Years 至 60 Years（—）
- 性别
- Male
入选标准
- •This study will be conducted in normal, healthy, adult, male subjects aged between 19-60 years and with a BMI < 27.5. Eligible subjects will have no history of clinically significant disease, or abnormality of the nasal passage that could interfere with administration or absorption of the study drug.
排除标准
- •- Clinically significant medical condition, which, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- •- A history of atrioventricular block, myocardial infarction (MI) or angina, non-sustained or sustained ventricular tachycardia (VT), family history of sudden death or prolonged QT interval, vaso-vagal syncope , sick sinus syndrome, supraventricular tachycardia, atrial flutter, Atrial fibrillation (AFib), stroke, transient ischemic attack (TIA), syncope, congestive heart failure (CHF), or Torsade de Pointes.
- •- Any acute or chronic condition of the nasal cavity
- •- Systolic blood pressure <110 or >150 mmHg, diastolic blood pressure <50 or >90 mmHg and heart rate (HR) <55or >95 bpm or an orthostatic fall in systolic BP at two minutes standing (from the 30 degree supine position) of >/= 15 mmHg.
- •Corrected QT (interval) using Fridericia’s correction (QTcF) >440 msec, flat or biphasic T waves, QRS >100ms, evidence of a prior MI, pathologic U waves or U waves that interfere with the QT measurement, or PR interval >200 ms or AV block or left anterior hemiblock (LAHB) or left posterior hemiblock (LPHB) or RBBB or LBBB; evidence of pre-excitation or PR interval <10 ms.
- •- Results from screening holter monitor showing:
- •a.Sustained first degree AV block with a PR >240ms for > 30min, or second or third degree AV block (blocked PAC’s are permitted);
- •b.Atrial fibrillation, atrial flutter, atrial tachycardias lasting > 8 beats, ventricular tachycardia (>3 beats in duration at a rate > 120 BPM);
- •c.Wolff–Parkinson–White syndrome with pre-excitation;
- •d.Sinus pauses >3 seconds unless due to blocked PAC’s; or
- •e.Significant sick sinus syndrome.
- •- Used nicotine-containing products within 6 weeks before screening and unable to abstain from using these products
- •- Unable to abstain from consuming caffeine and/or xanthine products for defined periods
- •- Known sensitivity to verapamil or adenosine.
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