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

ConditionPain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorVertex Pharmaceuticals Incorporated

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Suzetrigine

Treatment groups

12 Participants
are divided into 1 treatment group