COMPLETED

RE104 Clinical Lactation Study

Conditions

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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 obtain data necessary to characterize the elimination of RE104 and metabolites from breastmilk of health lactating volunteers to support a regulatory assessment of when mothers can safely return to breastfeeding following a single-dose of RE104 for Injection.

Official Title

A Phase 1, Open-label, Single Dose Study to Evaluate the Concentration of RE104 and Its Major Metabolites in Breast Milk and Plasma of Healthy Lactating Women.

Quick Facts

Study Start:2024-11-13

Study Completion:2025-06-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06659263

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 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Females between 18 and 45 years of age, at least 50 kgs, and a body mass index of 18-34 kg/m2 * Has been breastfeeding or actively pumping for at least 4 weeks postpartum * Agrees to cease breastfeeding for duration of study (Day 14) and confirms infant is able to feed from a bottle at screening. * Willing and able to pump in order to maintain sufficient milk supply volumes for the study * Is not pregnant or planning to become pregnant during the study * 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	* Has mastitis or other condition that would prevent the collection of milk from one or both breasts * Active or medical history of significant mental disorder (including but not necessarily limited to major depression and anxiety disorders, bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder), or first-degree family history of psychosis or bipolar disorder * Medically significant condition or other concomitant condition or history rendering unsuitability for the study, in the judgement of the investigator * Has used or intends to use of prohibited medications * Has a known sensitivity or intolerance to hallucinogenic or psychedelic substances, or potential rescue medications

Inclusion Criteria

Exclusion Criteria

* Females between 18 and 45 years of age, at least 50 kgs, and a body mass index of 18-34 kg/m2
* Has been breastfeeding or actively pumping for at least 4 weeks postpartum
* Agrees to cease breastfeeding for duration of study (Day 14) and confirms infant is able to feed from a bottle at screening.
* Willing and able to pump in order to maintain sufficient milk supply volumes for the study
* Is not pregnant or planning to become pregnant during the study
* 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

* Has mastitis or other condition that would prevent the collection of milk from one or both breasts
* Active or medical history of significant mental disorder (including but not necessarily limited to major depression and anxiety disorders, bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder), or first-degree family history of psychosis or bipolar disorder
* Medically significant condition or other concomitant condition or history rendering unsuitability for the study, in the judgement of the investigator
* Has used or intends to use of prohibited medications
* Has a known sensitivity or intolerance to hallucinogenic or psychedelic substances, or potential rescue medications

Contacts and Locations

Principal Investigator

Mark Pollack, Chief Medical Officer

STUDY_DIRECTOR

Reunion Neurosciences Inc

Study Locations (Sites)

PPD Inc

Las Vegas, Nevada, 89113

United States

Collaborators and Investigators

Sponsor: Reunion Neuroscience Inc

Mark Pollack, Chief Medical Officer, STUDY_DIRECTOR, Reunion Neurosciences 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 Date2024-11-13

Study Completion Date2025-06-04

Study Record Updates

Study Start Date2024-11-13

Study Completion Date2025-06-04

Terms related to this study

Additional Relevant MeSH Terms

Lactation