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 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
Exclusion Criteria
- 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
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 and 4-OH-DiPT in plasma Through 168 hours postdose Apparent volume of distribution during the terminal phase (Vz/F) for RE104 and 4-OH-DiPT 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 Total and daily infant dose (DID) of RE104 and its active entity 4-OH-DiPT Through 24 hour and 7 days postdose Total and daily infant dose (RID) of RE104 and its active entity 4-OH-DiPT Through 24 hour and 7 days postdose
- Secondary Outcome Measures
Name Time Method 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 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 total body clearance (CL/F) for detectable/quantifiable RE104 metabolites in plasma and breast milk Through 168 hours postdose Apparent volume of distribution during the terminal phase (Vz/F)for detectable/quantifiable RE104 metabolites in plasma 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 24 hour and 7 days postdose Unbound and bound plasma concentrations of the RE104 active entity 4-OH-DiPT. 1, 3 and 8 hours post-dose
Trial Locations
- Locations (1)
PPD Inc
🇺🇸Las Vegas, Nevada, United States