RE104 Clinical Lactation Study

Reunion Neuroscience Inc14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lactation

Interventions

RE104 for InjectionDRUG

Single, subcutaneous dose of RE104 for Injection

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PPD Inc

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Through 168 hours postdose

Maximum observed concentration (Cmax) for RE104 and 4-OH-DiPT in plasma and breast milk

Time frame: Through 168 hours postdose

Time to reach Cmax (tmax) for RE104 and 4-OH-DiPT in plasma and breast milk

Time frame: Through 168 hours postdose

Apparent total body clearance (CL/F) for RE104 in plasma

Time frame: Through 168 hours postdose

Apparent volume of distribution during the terminal phase (Vz/F) for RE104 in plasma

Time frame: Through 168 hours postdose

Apparent terminal elimination half-life (t1/2) for RE104 and 4-OH-DiPT in plasma

Time frame: Through 168 hours postdose

Milk to plasma (M/P) ratio for RE104 and 4-OH-DiPT in breast milk

Time frame: Through 168 hours postdose

Relative infant dose (RID) of RE104 and its active entity 4-OH-DiPT

Time frame: Through 72 hours postdose

Total RID of RE104 and its active entity 4-OH-DiPT

Time frame: Through 168 hours postdose

Data from ClinicalTrials.gov

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Incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.

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.

Time frame: From dosing through study completion (post-dose follow-up is for 14 days)

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

Time frame: 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

Time frame: Through 168 hours postdose

Maximum observed concentration (Cmax) for detectable/quantifiable RE104 metabolites in plasma and breast milk

Time frame: Through 168 hours postdose

Time to reach Cmax (tmax) for detectable/quantifiable RE104 metabolites in plasma and breast milk

Time frame: Through 168 hours postdose

Apparent terminal elimination half-life (t1/2) for detectable/quantifiable RE104 metabolites in plasma

Time frame: Through 168 hours postdose

Milk to plasma (M/P) ratio for detectable/quantifiable RE104 metabolites in breast milk

Time frame: 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)

Time frame: Through 168 hours postdose

Unbound and bound plasma concentrations of the RE104 active entity 4-OH-DiPT.

Time frame: 1, 3 and 8 hours post-dose

RE104 Clinical Lactation Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes