Actively Recruiting
Evaluation of the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Participants
Led by Vertex Pharmaceuticals Incorporated · Updated on 2026-05-13
12
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index of greater than or equal to (≥) 18.0 to less than (<) 40.0 kilogram per meter square (Kg/m²) 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)
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ICON - Utah - Salt Lake City Office
Salt Lake City, Utah, United States, 84124
Actively Recruiting
Research Team
M
Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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