A Phase 1 interventional study of RE104 for Injection in Lactation, sponsored by Reunion Neuroscience Inc. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Reunion Neuroscience Inc · Phase 1, Interventional, and Treatment
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.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's enrollment of 14 is below the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →Reunion Neuroscience Inc is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single subcutaneous injection of 30 mg RE104 for Injection
Drug: RE104 for Injection
Single, subcutaneous dose of RE104 for Injection
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
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
Plan to share: No — Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Reunion Neuroscience Inc