ICON - Utah - Salt Lake City Office
Salt Lake City, Utah, 84124, United States
Location status: Recruiting
NCT Number: NCT07378865
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 1
Salt Lake City, Utah, 84124, United States
Location status: Recruiting
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.).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
Tablets for Oral Administration.
Other names: VX-548, SUZ, JOURNAVX
Time frame: From Day 1 up to Day 10
Time frame: From Day 1 up to Day 10
Time frame: From Day 1 up to Day 10
Time frame: From Day 1 up to Day 10
Time frame: From Day 1 up to Day 10
Time frame: From Day 1 up to Day 16
Contact information is provided by the study sponsor or research team.
Vertex Pharmaceuticals Incorporated
Industry
A Phase 1, Open-label, Single-dose Study Evaluating the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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