Clinical trial NCT06659263: RE104 Clinical Lactation Study
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lactation
Lead sponsor: Reunion Neuroscience Inc
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Area under the concentration-time curve from time zero to 24 hours post-dose (AUC0 24) for RE104 and 4-OH-DiPT in plasma and breast milk
timeFrame: Through 24 hours postdose
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for RE104 and 4-OH-DiPT in plasma and breast milk
timeFrame: Through 168 hours postdose
measure: Maximum observed concentration (Cmax) for RE104 and 4-OH-DiPT in plasma and breast milk
timeFrame: Through 168 hours postdose
measure: Time to reach Cmax (tmax) for RE104 and 4-OH-DiPT in plasma and breast milk
timeFrame: Through 168 hours postdose
measure: Apparent total body clearance (CL/F) for RE104 in plasma
timeFrame: Through 168 hours postdose
measure: Apparent volume of distribution during the terminal phase (Vz/F) for RE104 in plasma
timeFrame: Through 168 hours postdose
measure: Apparent terminal elimination half-life (t1/2) for RE104 and 4-OH-DiPT in plasma
timeFrame: Through 168 hours postdose
measure: Milk to plasma (M/P) ratio for RE104 and 4-OH-DiPT in breast milk
timeFrame: Through 168 hours postdose
measure: Relative infant dose (RID) of RE104 and its active entity 4-OH-DiPT
timeFrame: Through 72 hours postdose
measure: Total RID of RE104 and its active entity 4-OH-DiPT
timeFrame: Through 168 hours postdose
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.
timeFrame: From dosing through study completion (post-dose follow-up is for 14 days)
measure: Area under the concentration-time curve from time zero to 24 hours post-dose (AUC0 24) for detectable/quantifiable RE104 metabolites in plasma and breast milk
timeFrame: Through 24 hours postdose
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for detectable/quantifiable RE104 metabolites in plasma and breast milk
timeFrame: Through 168 hours postdose
measure: Maximum observed concentration (Cmax) for detectable/quantifiable RE104 metabolites in plasma and breast milk
timeFrame: Through 168 hours postdose
measure: Time to reach Cmax (tmax) for detectable/quantifiable RE104 metabolites in plasma and breast milk
timeFrame: Through 168 hours postdose
measure: Apparent terminal elimination half-life (t1/2) for detectable/quantifiable RE104 metabolites in plasma
timeFrame: Through 168 hours postdose
measure: Milk to plasma (M/P) ratio for detectable/quantifiable RE104 metabolites in breast milk
timeFrame: Through 168 hours postdose
measure: Amount of RE104 and its active entity 4 OH-DiPT excreted into breast milk (Ae) and amount of drug excreted into breast milk relative to dose (Fe)
timeFrame: Through 168 hours postdose
measure: Unbound and bound plasma concentrations of the RE104 active entity 4-OH-DiPT.
timeFrame: 1, 3 and 8 hours post-dose
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: PPD Inc
state: Nevada
Study officials:
affiliation: Reunion Neurosciences Inc
name: Mark Pollack, Chief Medical Officer
role: STUDY_DIRECTOR
References: