Clinical Trial to Assess Effect of Verapamil on Systemic Exposure of EP395 and Effect of EP395 on… (NCT06118684) | Clinical Trial Compass
CompletedPhase 1
Clinical Trial to Assess Effect of Verapamil on Systemic Exposure of EP395 and Effect of EP395 on Systemic Exposure of Midazolam and Digoxin
Sweden37 participantsStarted 2023-10-23
Plain-language summary
The aim of this trial is to assess the potential key drug-drug interactions with EP395 in the clinical setting.
Who can participate
Age range
18 Years – 55 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
. Willing and able to understand the information on the nature, the scope, and the relevance of the trial, and to provide voluntary, written informed consent to participate in the trial before any trial-related procedures.
. Healthy male or female participant aged 18 to 55 years, inclusive.
. Body mass index ≥ 19.0 and ≤ 33.0 kg/m2 at the time of the screening visit.
. Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator.
. Non-smoker, or former smoker with \<10 pack years who stopped smoking (including e-cigarettes) at least 6 months before the screening visit.
. Women of childbearing potential (WOCBP) must:
. have a negative pregnancy test (blood) at the screening visit and (urine) Day 1.
. agree to use, and be able to comply with, highly effective measures of contraceptive control (failure rate less than 1% per year when used consistently and correctly) without interruption, during trial participation and until 90 days after the last IMP intake.
Exclusion criteria
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 of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results, or the participant's ability to participate in the trial.
. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the (first) administration of IMP.
. Presence or history of lung disease, e.g., asthma, chronic obstructive pulmonary disease.
. Presence or history of significant gastrointestinal medical condition that could lead to abnormal absorption.
. History of or active tuberculosis at the time of the screening visit based on participant anamnesis. Participants who have been living together with another person with active tuberculosis at any time over the past 10 years will also be excluded.
. Clinically significant abnormality on 12-lead ECG at the screening visit or Day 1 pre-dose, including prolonged QTcF (\>450 msec men or \>470 msec women) or PR interval \>210 msec.
. Abnormal renal function at the time of the screening visit:
. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 x ULN at the time of the screening visit.
Part A: PK parameters of EP395 - Vz/F
Timeframe: Days 1 to 6 and Day 14 to 19
9
Part B: PK parameters of midazolam and digoxin - AUC0-24
Timeframe: Days 1 to 3/6 and Day 24 to 29
10
Part B: PK parameters of midazolam and digoxin - AUC0-inf
Timeframe: Days 1 to 3/6 and Day 24 to 29
11
Part B: PK parameters of midazolam and digoxin - AUC%extrap
Timeframe: Days 1 to 3/6 and Day 24 to 29
12
Part B: PK parameters of midazolam and digoxin - Cmax
Timeframe: Days 1 to 3/6 and Day 24 to 29
13
Part B: PK parameters of midazolam and digoxin - Tmax
Timeframe: Days 1 to 3/6 and Day 24 to 29
14
Part B: PK parameters of midazolam and digoxin - T1/2