A Study of Etripamil in Healthy Subjects (NCT05511870) | Clinical Trial Compass
CompletedPhase 1
A Study of Etripamil in Healthy Subjects
China12 participantsStarted 2023-03-07
Plain-language summary
The objectives of the study are as below:
Primary:
·To evaluate the pharmacokinetics (PK) of Etripamil in healthy adult Chinese subjects
Secondary:
* To evaluate the pharmacodynamics (PD) of Etripamil in healthy adult Chinese subjects
* To evaluate the safety and tolerability of Etripamil in healthy adult Chinese subjects
Exploratory:
·To evaluate the PK exposure-PD response relationship of etripamil in healthy adult Chinese subjects
Who can participate
Age range18 Years – 45 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Ethnically Chinese men or women, 18 to 45 years of age (inclusive).
✓. Body weight: male ≥50 kg, female ≥45 kg; body mass index (BMI) within 18 to 26 kg/m2 (inclusive).
✓. Healthy subject as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital signs.
Exclusion criteria
✕. Non-smoker or ex-smoker for \>6 months.
✕. From the time they sign the informed consent to 90 days (male subject within 30 days) after dosing, subjects have no plans to have children and voluntarily use effective contraception
✕. Have a history of, or current clinically significant medical illness including but not limited to, cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; hepatic or renal disease; thyroid disease; neurologic or psychiatric disease; or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results.
✕. A history of atrioventricular (AV) block, (1st, 2nd or 3rd degree), myocardial infarction (MI) or angina, non-sustained or sustained ventricular tachycardia (VT), torsade de pointes, 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).
✕. Acute upper respiratory tract infection within 14 days prior to dosing.