Evaluation of the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Participants (NCT07378865) | Clinical Trial Compass
RecruitingPhase 1
Evaluation of the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Participants
United States12 participantsStarted 2026-02-13
Plain-language summary
The purpose of the study is to evaluate the pharmacokinetics (PK) of suzetrigine (SUZ) and its active metabolite in breast milk of lactating female participants. In addition, the purpose is also to evaluate the relative infant dose (RID), safety and tolerability of SUZ and its active metabolite in lactating female participants.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Body mass index of greater than or equal to (≥) 18.0 to less than (\<) 40.0 kilogram per meter square (Kg/m\^2) at the Screening Visit
* Participants between 6 weeks and 12 months (inclusive) postpartum from a pregnancy of at least 37 weeks gestation, as of Day 1
* Willing to perform regular pumping to maintain milk supply for the duration of the study
* Participants with well-established lactation, defined as breastfeeding and/or pumping at least 3 times per day
* Participant agrees to abstain from donating or feeding their infant any breast milk produced after receiving SUZ through the completion of the Safety Follow-up Visit (SFUV)
Key Exclusion Criteria:
* History of febrile illness or other acute illness that has not fully resolved within 14 days before study drug dosing
* History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from one or both breasts
* History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant
* Pregnant or planning to become pregnant during the study or within 30 days after receiving study drug
Other protocol defined Inclusion/Exclusion criteria may apply.
Questions worth asking your doctor
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
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.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Amount of SUZ in Breast Milk of Lactating Female Participants
Timeframe: From Day 1 up to Day 10
2
Total Amount of SUZ Metabolite in Breast Milk of Lactating Female Participants