A study to investigate the uptake, distribution, breakdown and excretion of a single dose of [14C]-etripamil administered with a nasal spray in healthy volunteers

Phase 1

• Conditions: Paroxysmal supraventricular tachycardia (PSVT); Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-004979-39-NL
• Lead Sponsor: Milestone Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-05
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 8

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

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 clinical trial of medicinal product
• Study Design: Not specified