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NCT Number: NCT07378865

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

ICON - Utah - Salt Lake City Office

Salt Lake City, Utah, 84124, United States

Location status: Recruiting

About this study

The study is being conducted to evaluate the PK, safety and tolerability of SUZ and its active metabolite in lactating female participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suzetrigine

Drug

Tablets for Oral Administration.

Other names: VX-548, SUZ, JOURNAVX

Primary outcomes

  1. Total Amount of SUZ in Breast Milk of Lactating Female Participants

    Time frame: From Day 1 up to Day 10

  2. Total Amount of SUZ Metabolite in Breast Milk of Lactating Female Participants

    Time frame: From Day 1 up to Day 10

Secondary outcomes

  1. Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of SUZ and its Metabolite in Breast Milk

    Time frame: From Day 1 up to Day 10

  2. Maximum Observed Concentration (Cmax) of SUZ and its Metabolite in Breast Milk

    Time frame: From Day 1 up to Day 10

  3. RID of SUZ and its Metabolite From Breast Milk

    Time frame: From Day 1 up to Day 10

  4. Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Day 1 up to Day 16

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Information

CONTACT

[email protected]

617-341-6777

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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