RecruitingPhase 1NCT07378865

Evaluation of the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Participants

A Phase 1, Open-label, Single-dose Study Evaluating the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Subjects

Sponsor

Vertex Pharmaceuticals Incorporated

Enrollment

12 participants

Start Date

Feb 13, 2026

Study Type

INTERVENTIONAL

Conditions

Pain

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria4

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

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