Suzetrigine passing into breast milk in healthy breastfeeding women

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

This test measures how much suzetrigine and its active metabolite get into breast milk and estimates the dose an infant might receive in healthy breastfeeding women 6 weeks to 12 months after delivery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Vertex Pharmaceuticals Incorporated (Industry-sponsored)
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT07378865 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional pharmacokinetic study enrolls healthy lactating women 6 weeks to 12 months postpartum to measure suzetrigine and its active metabolite in breast milk and plasma. Participants will provide regular pumped milk samples and blood samples according to a dosing and sampling schedule to calculate drug exposure and the relative infant dose (RID). Safety and tolerability will be monitored through clinical assessments and adverse event reporting through a safety follow-up visit. The study is sponsored by Vertex Pharmaceuticals and conducted at a site in Salt Lake City, Utah.

Who should consider this trial

Good fit: Healthy breastfeeding women 6 weeks to 12 months postpartum with BMI 18 to <40 kg/m2 who are willing to pump regularly and refrain from feeding or donating milk after dosing are the intended participants.

Not a fit: Women who are not breastfeeding, are outside the 6 weeks to 12 months postpartum window, have recent unresolved illness, or have breast surgery that affects milk collection are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, the results could help clinicians advise breastfeeding mothers about suzetrigine use by quantifying infant exposure and identifying safety signals.

How similar studies have performed: Measuring drug excretion into breast milk and calculating relative infant dose is a well-established approach used successfully for many medications, though suzetrigine itself appears novel in this context.

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 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.

Where this trial is running

Salt Lake City, Utah

• ICON - Utah - Salt Lake City Office — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Medical Information

Conditions Pain