A Study of EDG-15400 in Healthy Adults (NCT07177066) | Clinical Trial Compass
CompletedPhase 1
A Study of EDG-15400 in Healthy Adults
United States84 participantsStarted 2025-08-20
Plain-language summary
The purposes of this Phase 1 study of EDG-15400 are to:
1. Learn about the safety of EDG-15400 after single and multiple doses in healthy adults
2. Learn about how EDG-15400 is tolerated after single and multiples doses in healthy adults
3. Evaluate the amount of EDG-15400 in the blood and urine after single and multiple doses in healthy adults
4. Evaluate the effect of a meal on the amount of EDG-15400 that is in the blood in healthy adults
5. Evaluate whether the amount of EDG-15400 in the blood is similar for the suspension and tablet forms of EDG-15400 in healthy adults
Participants will receive a single or multiple doses of EDG-15400 or a placebo by mouth.
Who can participate
Age range
18 Years – 59 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 give informed consent and follow all study procedures and requirements.
. Healthy male or nonpregnant female, ages ≥18 to \<60 years.
. Body mass index (BMI) ≥18.5 to \<35 kg/m2; weight ≥55 kg at Screening.
. Absence of important health problems and essentially normal physical examination, normal laboratory screening tests, and normal electrocardiogram (ECG) with QTc interval corrected for heart rate using the Fridericia method (QTcF) ≤450 ms.
Exclusion criteria
. Evidence of clinically significant abnormalities or disease.
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.
What they're measuring
1
Safety: incidence of treatment-emergent adverse events
. Unless permitted by protocol, use of any prescription medication ≤ 4 weeks or investigational medication ≤ 12 weeks or ≤ 5 half-lives (whichever is longer) of dosing. Use of any non-prescription medication or herbal/nutritional supplement ≤ 5 days prior to dosing.
. Donation or loss of \> 1 unit (450 mL) of blood ≤ 1 month prior to dosing.
. Females: nursing, lactating, or pregnant.
. Females: breast implants.
. Use of nicotine-containing products in the last 6 months prior to dosing.
. History of substance abuse or dependency or history of recreational drug use within the last 2 years.
. Alcohol consumption \> 14 drinks per week for males (7 for females) within 45 days of screening.