A Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]-MRM-3379 (NCT07712718) | Clinical Trial Compass
RecruitingPhase 1
A Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]-MRM-3379
United States8 participantsStarted 2026-05-29
Plain-language summary
This is a Phase 1, open label study in healthy male participants to study the Absorption, Distribution, Metabolism, and Excretion of \[14C\]-MRM-3379 drug following a single oral dose.
Who can participate
Age range
18 Years – 55 Years
Sex
MALE
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
. Male of any race, between 18 and 55 years of age, inclusive.
. Body mass index between 18.0 and 32.0 kg/m2, inclusive, and a body weight between 50 and 110 kg, inclusive.
. In good health, as determined by medical history, and as assessed by the investigator (or designee).
. Able to comprehend and are willing to sign the ICF and abide by the trial restrictions.
Exclusion criteria
. History of or current medical condition that would place the participant at risk from study participation.
. Administration of any vaccine within 30 days prior to dosing.
. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, considered to potentially impact participant safety or the objectives of the trial, as determined by the investigator (or designee).
. Participation in a clinical trial involving administration of an IMP (new chemical entity) in the past 30 days or 5 half-lives of that drug (if known) prior to dosing, whichever is longer.
. Have previously completed or withdrawn from this trial or any other trial investigating MRM-3379 or have previously received MRM-3379.
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
Total radioactivity recovery of MRM-3379 in urine and feces
Timeframe: Up to 11 days post dose
2
Maximum observed concentration (Cmax) of MRM-3379 and 2 metabolites in plasma
Timeframe: Up to 11 days post dose
3
Time to maximum observed concentration (tmax) of MRM-3379 and 2 metabolites in plasma
Timeframe: up to 11 days post dose
4
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-tlast) of MRM-3379 and 2 metabolites in plasma
Timeframe: up to 11 days post dose
5
Maximum observed concentration (Cmax) of total radioactivity in plasma and whole blood
Timeframe: up to 11 days post dose
6
Time to maximum observed concentration (tmax) of total radioactivity in plasma and whole blood
Timeframe: up to 11 days post dose
7
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-tlast) of total radioactivity in plasma and whole blood
. Participants who have previously been dosed in \>2 radiolabeled drug studies in the last 12 months. For participants who have previously been dosed in ≤2 radiolabeled drug studies within the last 12 months, the previous radiolabeled dose must be at least 4 months prior to check-in to the trial site where exposures are known to the investigator or 6 months prior to check-in to the trial site for a radiolabeled drug trial where exposures are not known to the investigator. The total 12-month exposure from this trial and a maximum of 2 other previous radiolabeled studies must be within the CFR recommended levels considered safe, per US Title 21 CFR 361.1.
. Participants with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
. Participants who, in the opinion of the investigator (or designee), should not participate in this trial.
Timeframe: Up to 11 days post dose
8
Amount of MRM-3379 and 2 metabolites excreted in the urine (Ae) over sampling period
Timeframe: Up to 11 days post dose
9
Fraction of MRM-3379 and 2 metabolites excreted in the urine (Fe) as Ae/dose