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New treatment option for Pain
Official title Evaluation of the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Participants
ClinicalTrials.gov ID: NCT07378865
What this study is testing
What is Suzetrigine?
Suzetrigine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pain.
Also referred to as VX-548, SUZ.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
- Pregnant or planning to become pregnant during the study or within 30 days after receiving study drug Other protocol defined Inclusion/Exclusion...
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.