Study on how RE104 affects breastmilk in lactating women
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.
PHASE1 · Reunion Neuroscience Inc · NCT06659263
This study is testing how a medication called RE104 affects breastmilk in breastfeeding mothers to see when it’s safe for them to resume nursing after taking it.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Reunion Neuroscience Inc (industry) |
| Locations | 1 site (Las Vegas, Nevada) |
| Trial ID | NCT06659263 on ClinicalTrials.gov |
What this trial studies
This study aims to gather data on the elimination of RE104 and its metabolites from the breastmilk of healthy lactating volunteers. It involves administering a single dose of RE104 for Injection to participants who are breastfeeding and monitoring the effects over a 14-day period. The goal is to determine when mothers can safely resume breastfeeding after receiving the medication. Participants will be required to pump milk to maintain supply during the study.
Who should consider this trial
Good fit: Ideal candidates are healthy females aged 18 to 45 who have been breastfeeding for at least 4 weeks postpartum.
Not a fit: Patients with conditions like mastitis or significant mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical information to ensure the safety of breastfeeding mothers after receiving RE104.
How similar studies have performed: While this specific approach is novel, similar studies assessing drug elimination in breastmilk have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Las Vegas, Nevada
- PPD Inc — Las Vegas, Nevada, United States (RECRUITING)
Study contacts
- Study coordinator: Mark Pollack, Chief Medical Officer, M.D.
- Email: info@reunionneuro.com
- Phone: 1-888-880-REUN
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lactation