Open-Label, Mass Balance Study to Investigate the Absorption, Distribution, Metabolism And Excretion Of [14C]-Etripamil Nasal Spray After a Single Dose to Healthy Male Subjects.
- Conditions
- Heart arrhythmia10007521
- Registration Number
- NL-OMON50057
- Lead Sponsor
- Milestone Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
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.
Caucasian 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 30.0 kg/m2
at Screening.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method