Evaluation of the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Participants
Recruiting
Phase 1Interventional Study
Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
12 (estimated)
Sponsor
Vertex Pharmaceuticals Incorporated · Industry
Who this trial is looking for
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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.
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Eligibility Criteria
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…
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.
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