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

Phase 1Not Yet RecruitingNCT07378865

Vertex Pharmaceuticals Incorporated12 enrolled

Overview

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.

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.).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

SuzetrigineDRUG

Tablets for Oral Administration.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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.