Ensayos clínicos

Inclusion Criteria:

• Male or female, aged 18 years and older at Screening
• Has a history of PSVT
• Is scheduled for an electrophysiology study and catheter ablation
• Has provided written informed consent
• Agrees to use a medically accepted form of contraception or abstinence to prevent pregnancy. Males must agree to use an acceptable form of contraception or abstinence from the time of study drug administration through the Follow-up Visit. Females must agree to use an acceptable form of contraception or abstinence from Screening until 30 days following study drug administration. Post-menopausal female subjects must be amenorrheic for ≥ 12 months prior to Screening or ≥ 6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) prior to Screening, if they do not wish to use an acceptable form of contraception or abstinence. Acceptable forms of contraception include: A condom and an intrauterine device; A condom and hormonal contraception; A condom and a diaphragm; Sterilization of the subject or the subject's partner(s) (sterilization procedure must have been performed 3 or more months prior); Hysterectomy of the subject or the subject's partner(s)
• If a female of childbearing potential: Has a negative serum pregnancy test result at Screening (Screening must occur ≥7 days prior to randomization [ie, on or before Day -7]) and at the Treatment Visit (pre-PSVT induction); Has had a menstrual period within 28 days of the Treatment Visit.

Exclusion Criteria:

• Has a history of sensitivity to verapamil
• Is currently participating in another drug or device study, or has received an investigational drug or device within 30 days of Screening
• Has evidence of clinically significant cardiovascular, endocrine, gastrointestinal, hematologic, hepatic, immunologic, neurologic, oncologic, pulmonary, psychiatric, or renal disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of study results
• Is a female who is breast feeding, pregnant, or planning to become pregnant during the study period
• Has evidence of any clinically significant acute or chronic condition of the nasal cavity (e.g., rhinitis or deviated septum) which could interfere with IN administration of the study drug in either or both nasal cavities
• Has any of the following at screening: Systolic blood pressure <100 mmHg or >160 mmHg, Diastolic blood pressure <50 mmHg or >100 mmHg, or heart rate <50 bpm or >95 bpm
• Has evidence of hepatic impairment, defined as: Alanine aminotransferase or aspartate aminotransferase levels that are greater than or equal to 3× upper limit of normal (ULN) or Bilirubin levels that are greater than or equal to 2× ULN, unless due to Gilbert's syndrome
• Has evidence of renal impairment, defined as an estimated glomerular filtration rate <30 mL/min (Modification of Diet in Renal Disease method)
• Has taken digoxin, verapamil, diltiazem, or any Class I, II (e.g., beta blockers), or III antiarrhythmic drug less than the equivalent of 5 half-lives of this drug prior to the Treatment Visit
• Has taken amiodarone within 30 days of the Treatment Visit
• Has taken drugs of abuse which, in the opinion of the Investigator, would impact the validity of study results
• Has had myocardial infarction, percutaneous coronary intervention, cerebrovascular accident, transient ischemic attack, unstable angina, or acute decompensation of heart failure within 6 months of Screening
• Has a history or evidence of second- or third-degree atrioventricular block
• Has a pacemaker or implantable cardioverter defibrillator
• Has a history of preexcitation syndrome (e.g., Wolf-Parkinson-White syndrome, short PR, etc.)
• Has evidence of a QT interval (Bazett's correction) (QTcB) >440 milliseconds
• Has a history or evidence of familial long QT syndrome, torsades de pointes, ventricular fibrillation, sustained ventricular tachycardia, Brugada syndrome, or sudden cardiac death
• Has evidence of recurrent or chronic atrial tachycardia, atrial flutter, or atrial fibrillation; that could interfere with the current investigation; or
• Has a history or evidence of congestive heart failure (except New York Heart Association Class I) or pulmonary edema