Healthy Participant StudyPhase 1NCT07146191
RE104 Radiolabeled Mass Balance (hAME) Study
A Phase 1 study testing 2-[14C]-RE104 for Injection in people with Healthy Participant Study, run by Reunion Neuroscience Inc at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participant Study
- What is being tested?
- 2-[14C]-RE104 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2025to 2 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 55 years of age (inclusive), and a body mass index of 18-34 kg/m2.
- Willing to take a drug with psychoactive properties
- If female and of childbearing potential, agrees to use an acceptable method of birth control and is not planning to become pregnant before, during or within 90 days after the last dose of the study drug.
- If male, must agree to use condom with spermicide during and up to 90 days after discharge."
- Must agree to refrain from sperm or egg donation until 120 days post discharge.
- Able to understand and adhere to study schedule and requirements and willing to sign an ICF
- In good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening
- Agrees to not participate in other research studies involving investigational medication or medical devices for the duration of the study
Who cannot join
- Active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder.
- Medical condition or other concomitant condition or history rendering unsuitability for the study
- Has used or intends to use prohibited medications
- Has a known sensitivity or intolerance to hallucinogenic or psychedelic substances, or potential rescue medications
- Has participated in another clinical study within 30 days and/or with a [14C] labeled study drug within 1 year prior to enrolling.
- Is pregnant or has a female partner who is pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Single Period Study to Evaluate the Absorption, Metabolism, and Excretion of a Single Microdose of [14C]-RE104 in Healthy Participants
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.
- Conditions
- Healthy Participant Study
- Being tested
- 2-[14C]-RE104 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-[14C]-RE104 for InjectionDrug
Single, subcutaneous dose of 2-[14C]-RE104 for Injection
| Study group | Role | What they receive |
|---|---|---|
| 30 mg 2-[14C]-RE104 (1uCi/30mg) | Experimental | A single subcutaneous injection of 30 mg 2-[14C]-RE104 for Injection Receives: Drug: 2-[14C]-RE104 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total excreted radioactivity (Ae)
Measured: Through 168 hours postdose
Cumulative recovery of total excreted radioactivity (CUM Ae)
Measured: Through 168 hours postdose
Area under the concentration-time curve (AUC) for RE104 and 4-OH-DiPT
Measured: Through 168 hours postdose
Maximum observed concentration (Cmax) for RE104 and 4-OH-DiPT
Measured: Through 168 hours postdose
Time to reach Cmax (Tmax) for RE104 and 4-OH-DiPT
Measured: Through 168 hours postdose
Terminal half-life (t1/2) of RE104 and 4-OH-DiPT
Measured: Through 168 hours postdose
Apparent terminal elimination half-life (λz) for RE104 and 4-OH-DiPT
Measured: Through 168 hours postdose
Mean residence time (MRT)
Measured: Through 168 hours postdose
Apparent total body clearance (CL/F) for RE104
Measured: Through 168 hours postdose
Apparent volume of distribution during the terminal phase (Vz/F) for RE104
Measured: Through 168 hours postdose
Total metabolite profiling with description of relevant PK parameters and structural identification of major metabolites present in all matrices
Measured: Through 168 hours postdose
Secondary outcomes (1)
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.
Measured: From dosing (Day 0) through study completion (Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start19 Aug 2025
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participant StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reunion Neuroscience Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Pollack, Chief Medical Officer, Study director, Reunion Neuroscience Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146191
- Sponsor's protocol ID
- RE104-103-NHV
- Status last verified
- Nov 2025
- First submitted
- 13 Aug 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single Period Study to Evaluate the Absorption, Metabolism, and Excretion of a Single Microdose of [14C]-RE104 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07146191
- Acronym / sponsor ID
- RE104-103-NHV
- Conditions
- Healthy Participant Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Reunion Neuroscience IncIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 mg 2-[14C]-RE104 (1uCi/30mg) | Experimental | Drug: 2-[14C]-RE104 for InjectionA single subcutaneous injection of 30 mg 2-[14C]-RE104 for Injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Between 18 and 55 years of age (inclusive), and a body mass index of 18-34 kg/m2.
- Willing to take a drug with psychoactive properties
- If female and of childbearing potential, agrees to use an acceptable method of birth control and is not planning to become pregnant before, during or within 90 days after the last dose of the study drug.
- If male, must agree to use condom with spermicide during and up to 90 days after discharge."
- Must agree to refrain from sperm or egg donation until 120 days post discharge.
Key exclusion criteria (6 listed)
- Active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder.
- Medical condition or other concomitant condition or history rendering unsuitability for the study
- Has used or intends to use prohibited medications
- Has a known sensitivity or intolerance to hallucinogenic or psychedelic substances, or potential rescue medications
- Has participated in another clinical study within 30 days and/or with a [14C] labeled study drug within 1 year prior to enrolling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-[14C]-RE104 for InjectionSingle, subcutaneous dose of 2-[14C]-RE104 for Injection | Drug | 30 mg 2-[14C]-RE104 (1uCi/30mg) |
Primary outcome
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
1 secondary outcome
Incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness
Time frame: From dosing (Day 0) through study completion (Day 7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Pollack, Chief Medical Officer study director
Reunion Neuroscience Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2-[14C]-RE104 for Injection in people with Healthy Participant Study, run by Reunion Neuroscience Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total excreted radioactivity (Ae) (time frame: Through 168 hours postdose). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.