Single and Multiple Ascending Dose Study With EP395 (NCT04819854) | Clinical Trial Compass
CompletedPhase 1
Single and Multiple Ascending Dose Study With EP395
United Kingdom78 participantsStarted 2021-04-05
Plain-language summary
This is a study to asses the safety and tolerability of single and multiple ascending doses of EP395, administered by oral capsules, in healthy subjects with the aim to determine the safe dose range of EP395 for further clinical development
Who can participate
Age range
18 Years – 65 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
. Subject's written informed consent obtained prior to any study-related procedures.
. Able to understand and comply with the requirements of the study, as judged by the investigator or designee.
. Men and women between 18-65 years inclusive
. Female subjects must either be of non-childbearing potential or if of childbearing potential, must not be pregnant or breast feeding and use a highly effective birth control method during treatment and for 90 days following last dose
. Male subjects must use highly effective contraception during treatment and for 90 days following last administered dose
. Subject must agree not to donate semen or ova/oocytes during the study and for 90 days after the last dose of IMP
. Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2.
. Subjects with normal hearing
Exclusion criteria
. History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety.
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.
. History or presence of vestibular disorder including vertigo, dizziness or other auditory impairment as judged by the investigator or designee.
. After 10 minutes supine rest at the time of screening or prior to dosing, any vital signs values outside the following ranges:
. Any clinically significant abnormalities in resting ECG at the time of screening or pre-dose Day 1 including prolonged QTcF (\>450 ms for males; \>470 ms for females) and cardiac arrhythmias, as judged by the Investigator or designee.
. Clinically significant abnormalities in renal function:
. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP (Day 1).
. Malignancy within the past five years with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps.
. Any planned major surgery within the duration of the study.