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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Vertex Pharmaceuticals Incorporated
Study ID
NCT07378865
Phase
PHASE1
Status
Recruiting
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Conditions

  • Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Suzetrigine — DRUG
    Tablets for Oral Administration.

Study Details

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.

Key Dates

Start date
Feb 13, 2026
Status verified
Jan 2026
Primary completion
Feb 26, 2027
Completion
Feb 26, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SUZ
    Participants will receive a single dose of SUZ on Day 1.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ICON - Utah - Salt Lake City OfficeSalt Lake CityUtah84124-

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ICON - Utah - Salt Lake City Office· Salt Lake City, UT

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