A Open-label, Drug-Drug Interaction With SB_MDZ in Healty Adult Subjects (NCT06846684) | Clinical Trial Compass
CompletedPhase 1
A Open-label, Drug-Drug Interaction With SB_MDZ in Healty Adult Subjects
South Korea12 participantsStarted 2025-03-27
Plain-language summary
This clinical trial is a phase 1, open-label, fixed-sequence, drug-drug interaction study to investigate the effect of single and multiple oral doses of SB17170 on the pharmacokinetics of SB\_MDZ in healthy adult subjects.
Who can participate
Age range
19 Years – 50 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
. Healthy adult subjects aged 19 to 50 years at the time of written consent.
. Individuals with a body weight of ≥ 50.0 kg, and a Body Mass Index(BMI) of ≥ 18.0 kg/m2 and \< 30.0 kg/m2 at the time of screening ☞ BMI(kg/m2) = weight(kg) / {height(m)}2
. Individuals who have voluntarily provided written consent to participate in the trial, after being fully informed about the study and agreeing to follow all precautions associated with participation.
Exclusion criteria
. Individuals with a clinically significant disease or history in hepatobiliary, renal, nervous, respiratory, immune, hemato-oncology, cardiovascular, urinary system, or psychiatric disorder
. Individuals with a history of a gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc) or surgeries (except for simple appendectomy or hernia surgery) that may affect the safety and pharmacokinetic assessment of the investigational product (IP)
. Individuals with hypersensitivity or significant history of hypersensitivity to drugs, including ingredients of the IP (SB17170 or its metabolite SB1703, SB\_MDZ, and benzodiazepine-class drugs) or other drugs (e.g., aspirin, antibiotics)
. Individuals with a current or historical condition that may increase risk, as determined by the investigator or as indicated in SB\_MDZ's product information
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.