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

Официальное название

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

Обзор

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.

Подробное описание

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.).

Вмешательства

• Препарат Suzetrigine
  Tablets for Oral Administration.

Первичные конечные точки

• Total Amount of SUZ in Breast Milk of Lactating Female Participants [Срок оценки: From Day 1 up to Day 10]
• Total Amount of SUZ Metabolite in Breast Milk of Lactating Female Participants [Срок оценки: From Day 1 up to Day 10]

Вторичные конечные точки (4)

• 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 [Срок оценки: From Day 1 up to Day 10]
• Maximum Observed Concentration (Cmax) of SUZ and its Metabolite in Breast Milk [Срок оценки: From Day 1 up to Day 10]
• RID of SUZ and its Metabolite From Breast Milk [Срок оценки: From Day 1 up to Day 10]
• Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From Day 1 up to Day 16]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• ICON - Utah - Salt Lake City Office — Salt Lake City

Идентификаторы

NCT: NCT07378865 · VX25-548-021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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