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 sites48 target enrollmentSeptember 2, 2013

ConditionsThis 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

Overview

Phase: Not Applicable
Intervention: Not specified
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.
Sponsor: CPR Pharma Services
Enrollment: 48
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 2, 2013

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

CPR Pharma Services

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•\- 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