An 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

Milestone Pharmaceuticals Inc.0 个研究点目标入组 8 人开始时间: 2020年2月5日最近更新: 2020年12月7日

适应症

试验速览

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•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

•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.

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