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New pain Drug's breast milk safety under the microscope

NCT ID NCT07378865

Knowledge-focused Sponsor: Vertex Pharmaceuticals Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This early-stage study is testing how much of the pain medication suzetrigine (JOURNAVX) gets into breast milk after a single dose. Twelve healthy breastfeeding women will provide milk samples to measure the drug and its breakdown product. The goal is to estimate how much a nursing baby might be exposed to, which could guide future use of this drug during breastfeeding.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
suzetrigine (also known as VX-548, JOURNAVX)
What this could lead to
If it works, this could help determine whether suzetrigine is safe to use while breastfeeding, guiding pain treatment options for nursing mothers.
What could go wrong
This is a very early, small study (12 people) that only measures drug levels in milk, not actual effects on infants. It may not reflect real-world use or long-term safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

13 people

The number who actually took part.

Started

Feb 2026

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pain

Contacts and locations

Locations

  • ICON - Utah - Salt Lake City Office

    Salt Lake City, Utah, 84124, United States

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Other studies related to the condition(s) this trial covers.