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

Official title

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

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.

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.).

Interventions

• Drug Suzetrigine
  Tablets for Oral Administration.

Primary outcome measures

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

Secondary outcome measures (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 [Time frame: From Day 1 up to Day 10]
• Maximum Observed Concentration (Cmax) of SUZ and its Metabolite in Breast Milk [Time frame: From Day 1 up to Day 10]
• RID of SUZ and its Metabolite From Breast Milk [Time frame: 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) [Time frame: From Day 1 up to Day 16]

Eligibility criteria

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)

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

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

Identifiers

NCT: NCT07378865 · VX25-548-021

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗