RE104 Radiolabeled Mass Balance (hAME) Study

NCT07146191 | Completed Phase 1 FDA Drug

• 1 other identifier: RE104-103-NHV
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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 of \[14C\]-RE104.

Conditions

Healthy Participant Study

Outcome Measures

Primary Outcomes (11)

• Total excreted radioactivity (Ae)

  Through 168 hours postdose

• Cumulative recovery of total excreted radioactivity (CUM Ae)

  Through 168 hours postdose

• Area under the concentration-time curve (AUC) for RE104 and 4-OH-DiPT

  Through 168 hours postdose

• Maximum observed concentration (Cmax) for RE104 and 4-OH-DiPT

  Through 168 hours postdose

• Time to reach Cmax (Tmax) for RE104 and 4-OH-DiPT

  Through 168 hours postdose

• Terminal half-life (t1/2) of RE104 and 4-OH-DiPT

  Through 168 hours postdose

• Apparent terminal elimination half-life (λz) for RE104 and 4-OH-DiPT

  Through 168 hours postdose

• Mean residence time (MRT)

  Through 168 hours postdose

• Apparent total body clearance (CL/F) for RE104

  Through 168 hours postdose

• Apparent volume of distribution during the terminal phase (Vz/F) for RE104

  Through 168 hours postdose

• Total metabolite profiling with description of relevant PK parameters and structural identification of major metabolites present in all matrices

  Through 168 hours postdose

Secondary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness

  From dosing (Day 0) through study completion (Day 7)

Study Arms (1)

30 mg 2-[14C]-RE104 (1uCi/30mg)

EXPERIMENTAL

A single subcutaneous injection of 30 mg 2-\[14C\]-RE104 for Injection

Drug: 2-[14C]-RE104 for Injection

Interventions

2-[14C]-RE104 for Injection DRUG

Single, subcutaneous dose of 2-\[14C\]-RE104 for Injection

30 mg 2-[14C]-RE104 (1uCi/30mg)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reunion Neuroscience Inc: lead

Study Sites (1)

PPD Inc.

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mark Pollack, Chief Medical Officer

  Reunion Neuroscience Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 28, 2025
• Study Start: August 19, 2025
• Primary Completion: October 2, 2025
• Study Completion: October 2, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

US (1)