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.
Age range
18 Years – 45 Years
Sex
FEMALE
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Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
Timeframe: 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
Timeframe: Through 168 hours postdose
Maximum observed concentration (Cmax) for RE104 and 4-OH-DiPT in plasma and breast milk
Timeframe: Through 168 hours postdose
Time to reach Cmax (tmax) for RE104 and 4-OH-DiPT in plasma and breast milk
Timeframe: Through 168 hours postdose
Apparent total body clearance (CL/F) for RE104 in plasma
Timeframe: Through 168 hours postdose
Apparent volume of distribution during the terminal phase (Vz/F) for RE104 in plasma
Timeframe: Through 168 hours postdose
Apparent terminal elimination half-life (t1/2) for RE104 and 4-OH-DiPT in plasma
Timeframe: Through 168 hours postdose
Milk to plasma (M/P) ratio for RE104 and 4-OH-DiPT in breast milk
Timeframe: Through 168 hours postdose
Relative infant dose (RID) of RE104 and its active entity 4-OH-DiPT
Timeframe: Through 72 hours postdose
Total RID of RE104 and its active entity 4-OH-DiPT
Timeframe: Through 168 hours postdose