Paroxysmal supraventricular tachycardia (PSVT)
Conditions
Interventions
Product Name: Etripamil Nasal Spray
Product Code: MSP-2017
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: Etripamil
CAS Number: 1593673-23-4
Current Sponsor code: MSP-2017
Concentrati
Sponsors
Milestone Pharmaceuticals Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Able to provide informed consent to participate in this study after reading the participant information sheet and informed consent form and after having the opportunity to discuss the study with the Investigator or designee. Healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory and other tests at Screening. Male subjects, aged 18 to 65 years (inclusive) at Screening. A body weight of =60 kg and a body mass index ranging from 18.0 to 35.0 kg/m2 at Screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance. History or current clinically significant cardiovascular, gastrointestinal, hepatic, renal, respiratory, metabolic, immunologic, hormonal disorders. 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), unexplained syncope, congestive heart failure (CHF), or Torsade de Pointes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the ratio of parent drug to metabolites in the circulation. Profiling of [14C]-etripamil metabolites in blood, urine and feces. To determine the mass balance of drug-related materials following intranasal administration. To determine the primary route of excretion of drug-related materials. To determine the total radioactivity versus time profile in plasma and whole blood. ;Secondary Objective: To evaluate the safety and tolerability of [14C]-etripamil after a single intranasal dose. To determine the pharmacokinetics (PK) in plasma and urine after a single dose of [14C]-etripamil nasal spray to healthy male subjects. ;Primary end point(s): Whole blood: Maximum observed total radioactivity (Cmax). Time from time zero to peak total radioactivity (tmax). Area under the total radioactivity-time curve from time zero to the last measurable concentration (AUC0-t). Area under the total radioactivity-time curve from time zero to infinity (AUC0-inf). Plasma: Maximum observed total radioactivity (Cmax). Time from time zero to peak total radioactivity (tmax). Area under the total radioactivity-time curve from time zero to the last measurable concentration of total radioactivity (AUC0-t). Area under the total radioactivity-time curve from time zero to infinity (AUC0-inf). Total radioactivity half-life (t1/2). Total radioactivity clearance (CL/F) and volume of distribution (Vz/F). [14C]-metabolic profile and identification of metabolites in plasma and/or blood. Urine: Total radioactivity amount excreted in urine (Aeu). Total radioactivity excreted in urine as a percentage of the radioactive dose. [14C]-metabolic profile and identification of metabolites in urine. Major radioactive peak/metabolite(s) in the urine radiochromatogram(s) as a percentage of the radioactive dose. Feces: Total radioactivity amount excreted in feces (Aef). Total radioactivity percentage dose excreted. [14C]-metabolic profile and identification of metabolites in feces. Majo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following are defined as safety/tolerability parameters: Adverse events (AEs); Vital signs (blood pressure, pulse rate, temporal temperature); 12-lead ECG; Telemetry; Clinical laboratory parameters; Physical examination. The following PK parameters will be calculated for etripamil (MSP-2017) and its main inactive metabolite MSP-2030, whenever possible and appropriate: Plasma: Maximum observed etripamil concentration (Cmax). Time from time zero to peak etripamil concentration (tmax). Area under the etripamil concentration-time curve from time zero to the last measurable concentration (AUC0-t). Area under the etripamil concentration-time curve from time zero to infinity (AUC0-inf). Etripamil half-life (t1/2). Etripamil clearance (CL/F) and volume of distribution (Vz/F). Urine: Amount excreted unchanged in urine (Aeu). Amount excreted unchanged in urine over a given time interval (Aeu,0-t). Fraction of dose excreted in urine (etripamil only) (fe/F). Renal clearance, calculated as Aeu,0-t/AUC0-t (CLr). ;Timepoint(s) of evaluation of this end point: during the study | — |
Countries
Netherlands
Contacts
Public ContactDouglas Wight
Milestone Pharmaceuticals Inc.
Outcome results
None listed