RE104 Clinical Lactation Study

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.

Conditions

Lactation

Study Overview

Study Details

Study overview

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.

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.

RE104 Clinical Lactation Study

Condition
Lactation
Intervention / Treatment

-

Contacts and Locations

Las Vegas

PPD Inc, Las Vegas, Nevada, United States, 89113

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Females between 18 and 45 years of age, at elast 50 kgs, and a body mass index of 18-34 kg/m2
  • * Has had a normal term pregnancy and has been breastfeeding or activley pumping for at least 4 weeks pospartum
  • * 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 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

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Reunion Neuroscience Inc,

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

Study Record Dates

2025-07