NCT07378865

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.).

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Suzetrigine	Tablets for Oral Administration.

Timeline

• Start date: 2026-02-13
• Primary completion: 2027-02-26
• Completion: 2027-02-26
• First posted: 2026-01-30
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study