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 range
18 Years – 45 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. Any abnormality of the nasal passage.
. Unable to tolerate IN administration.
. Known sensitivity to verapamil or other drugs or foods.