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RE104 Radiolabeled Mass Balance (hAME) Study

NCT07146191 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-11-20

No results posted yet for this study

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

Interventions

DRUG

2-[14C]-RE104 for Injection

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

Sponsors & Collaborators

  • Reunion Neuroscience Inc

    lead INDUSTRY

Principal Investigators

  • Mark Pollack, Chief Medical Officer · Reunion Neuroscience Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-19
Primary Completion
2025-10-02
Completion
2025-10-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07146191 on ClinicalTrials.gov