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

Vertex Pharmaceuticals

Status and phase

Not yet enrolling

Phase 1

Conditions

Pain

Treatments

Drug: Suzetrigine

Study type

Interventional

Funder types

Industry

Identifiers

NCT07378865

VX25-548-021

Details and patient eligibility

About

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.

Full 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.).

Enrollment

12 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.