RE104 Clinical Lactation Study
Phase 1
Recruiting
- Conditions
- Lactation
- Interventions
- Drug: RE104 for Injection
- Registration Number
- NCT06659263
- Lead Sponsor
- Reunion Neuroscience Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 30 mg RE104 RE104 for Injection A single subcutaneous injection of 30 mg RE104 for Injection
- Primary Outcome Measures
Name Time Method 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 Total RID of RE104 and its active entity 4-OH-DiPT Through 168 hours postdose
- Secondary Outcome Measures
Name Time Method 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.
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
Trial Locations
- Locations (1)
PPD Inc
🇺🇸Las Vegas, Nevada, United States