Recruiting
Phase 1

Suzetrigine

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT07378865

Conditions

Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Suzetrigine

Study Details

Brief 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.

Conditions

Pain

Study ID

NCT07378865

Start date

Feb 13, 2026

Status verified date

Jan, 2026

Completion date

Feb 26, 2027

Anticipated

Primary completion date

Feb 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SUZ

Participants will receive a single dose of SUZ on Day 1.

Interventions

Suzetrigine

Tablets for Oral Administration.

Primary outcome measure

  • Total Amount of SUZ in Breast Milk of Lactating Female Participants [ Time Frame: From Day 1 up to Day 10 ]
  • Total Amount of SUZ Metabolite in Breast Milk of Lactating Female Participants [ Time Frame: From Day 1 up to Day 10 ]

Central Contacts and Locations

Central contacts

Medical Information

617-341-6777medicalinfo@vrtx.com

Locations

ICON - Utah - Salt Lake City Office

Recruiting

Salt Lake City, Utah, United States, 84124

More Information

Sponsor

Vertex Pharmaceuticals Incorporated

Last update posted

May 13, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-05-13.