A Phase 1 interventional study of 2-[14C]-RE104 for Injection in Healthy Participant Study, sponsored by Reunion Neuroscience Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Reunion Neuroscience Inc · Phase 1, Interventional, and Treatment
The purpose of this study is to characterize the absorption, metabolism and routes of excretion of RE104 and its metabolites in healthy volunteers. This study will quantify drug and metabolites in blood, urine, and feces samples collected before study drug administration and through at least 168 hours after SC dosing of [14C]-RE104.
Reunion Neuroscience Inc is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single subcutaneous injection of 30 mg 2-\[14C\]-RE104 for Injection
Drug: 2-[14C]-RE104 for Injection
Single, subcutaneous dose of 2-\[14C\]-RE104 for Injection
Total excreted radioactivity (Ae)
Time frame: Through 168 hours postdose
Cumulative recovery of total excreted radioactivity (CUM Ae)
Time frame: Through 168 hours postdose
Area under the concentration-time curve (AUC) for RE104 and 4-OH-DiPT
Time frame: Through 168 hours postdose
Maximum observed concentration (Cmax) for RE104 and 4-OH-DiPT
Time frame: Through 168 hours postdose
Time to reach Cmax (Tmax) for RE104 and 4-OH-DiPT
Time frame: Through 168 hours postdose
Terminal half-life (t1/2) of RE104 and 4-OH-DiPT
Time frame: Through 168 hours postdose
Apparent terminal elimination half-life (λz) for RE104 and 4-OH-DiPT
Time frame: Through 168 hours postdose
Mean residence time (MRT)
Time frame: Through 168 hours postdose
Apparent total body clearance (CL/F) for RE104
Time frame: Through 168 hours postdose
Apparent volume of distribution during the terminal phase (Vz/F) for RE104
Time frame: Through 168 hours postdose
Total metabolite profiling with description of relevant PK parameters and structural identification of major metabolites present in all matrices
Time frame: Through 168 hours postdose
Incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness
A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug.
Time frame: From dosing (Day 0) through study completion (Day 7)
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Reunion Neuroscience Inc