RECRUITING

RE104 Radiolabeled Mass Balance (hAME) Study

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-08-19

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07146191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Between 18 and 45 years of age, at least 50 kgs, 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	* 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 of prohibited medications * Has a known sensitivity or intolerance to hallucinogenic or psychedelic substances, or potential rescue medications * Has not participated in another clinical study within 30 days and/or with a \[14C\] labeled study drug within 1 year prior to enrolling. * Has a female partner who is pregnant

Inclusion Criteria

Exclusion Criteria

* Between 18 and 45 years of age, at least 50 kgs, 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

* 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 of prohibited medications
* Has a known sensitivity or intolerance to hallucinogenic or psychedelic substances, or potential rescue medications
* Has not participated in another clinical study within 30 days and/or with a \[14C\] labeled study drug within 1 year prior to enrolling.
* Has a female partner who is pregnant

Contacts and Locations

Study Contact

Mark Pollack, Chief Medical Officer, M.D.

CONTACT

1-888-880-REUN

info@reunionneuro.com

Principal Investigator

Mark Pollack, Chief Medical Officer

STUDY_DIRECTOR

Reunion Neuroscience Inc

Study Locations (Sites)

PPD Inc.

Austin, Texas, 78744

United States

Collaborators and Investigators

Sponsor: Reunion Neuroscience Inc

Mark Pollack, Chief Medical Officer, STUDY_DIRECTOR, Reunion Neuroscience Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-19

Study Completion Date2025-10

Study Record Updates

Study Start Date2025-08-19

Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

Healthy Participant Study