Evaluation of the Excretion of Suzetrigine Into Breast Mi... | NCT07378865

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

NCT07378865

Sponsor

Vertex Pharmaceuticals Incorporated

Status

Recruiting

Last Update Posted

May 13, 2026Actual

Enrollment

12Estimated

Phase

Phase 1

Conditions

Pain

Interventions

Suzetrigine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2026Actual

Primary Completion Date

Feb 26, 2027Estimated

Completion Date

Feb 26, 2027Estimated

First Submitted Date

Jan 23, 2026

First Submission Date that Met QC Criteria

Jan 23, 2026

First Posted Date

Jan 30, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2026

Last Update Posted Date

May 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Label	Type	Description	Intervention Names
SUZ	Experimental	Participants will receive a single dose of SUZ on Day 1.	Drug: Suzetrigine

Name	Type	Description	Arm Group Labels	Other Names
Suzetrigine	Drug	Tablets for Oral Administration.	SUZ	VX-548

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Amount of SUZ in Breast Milk of Lactating Female Participants		From Day 1 up to Day 10
Total Amount of SUZ Metabolite in Breast Milk of Lactating Female Participants		From Day 1 up to Day 10

Secondary Outcomes

Measure	Description	Time Frame
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		From Day 1 up to Day 10
Maximum Observed Concentration (Cmax) of SUZ and its Metabolite in Breast Milk

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Medical Information	Contact	617-341-6777		medicalinfo@vrtx.com

Facility	Status	City	State	ZIP	Country	Contacts
ICON - Utah - Salt Lake City Office	Recruiting	Salt Lake City	Utah	84124	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms