A study in healthy males to assess the safety and tolerability of two different formulations of the study drug, (MSP-2017), administered intranasally.
- Conditions
- This study is for healthy volunteers. The intended use of the investigational product is to self-terminate acute episodes of paroxysmal supraventricular tachycardia (PSVT), a non-life threatening cardiac arrhythmia.Cardiovascular - Coronary heart disease
- Registration Number
- ACTRN12613000971730
- Lead Sponsor
- CPR Pharma Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 48
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method