Lactation
Conditions
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.
Interventions
Single, subcutaneous dose of RE104 for Injection
Sponsors
Reunion Neuroscience Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total RID of RE104 and its active entity 4-OH-DiPT | Through 168 hours postdose |
| 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 | Through 24 hours postdose |
| 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 | Through 168 hours postdose |
| Maximum observed concentration (Cmax) for RE104 and 4-OH-DiPT in plasma and breast milk | Through 168 hours postdose |
| Time to reach Cmax (tmax) for RE104 and 4-OH-DiPT in plasma and breast milk | Through 168 hours postdose |
| Apparent total body clearance (CL/F) for RE104 in plasma | Through 168 hours postdose |
| Apparent volume of distribution during the terminal phase (Vz/F) for RE104 in plasma | Through 168 hours postdose |
| Apparent terminal elimination half-life (t1/2) for RE104 and 4-OH-DiPT in plasma | Through 168 hours postdose |
| Milk to plasma (M/P) ratio for RE104 and 4-OH-DiPT in breast milk | Through 168 hours postdose |
| Relative infant dose (RID) of RE104 and its active entity 4-OH-DiPT | Through 72 hours postdose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Through 24 hours postdose | — |
| 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 | Through 168 hours postdose | — |
| Maximum observed concentration (Cmax) for detectable/quantifiable RE104 metabolites in plasma and breast milk | Through 168 hours postdose | — |
| Time to reach Cmax (tmax) for detectable/quantifiable RE104 metabolites in plasma and breast milk | Through 168 hours postdose | — |
| Apparent terminal elimination half-life (t1/2) for detectable/quantifiable RE104 metabolites in plasma | Through 168 hours postdose | — |
| Milk to plasma (M/P) ratio for detectable/quantifiable RE104 metabolites in breast milk | Through 168 hours postdose | — |
| 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) | Through 168 hours postdose | — |
| Unbound and bound plasma concentrations of the RE104 active entity 4-OH-DiPT. | 1, 3 and 8 hours post-dose | — |
| Incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness. | From dosing through study completion (post-dose follow-up is for 14 days) | A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug. |
Countries
United States
Outcome results
None listed