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NCT07378865 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Pain, sponsored by Vertex Pharmaceuticals Incorporated.

Recruiting
Registry status
Phase 1
Development phase
12
Enrollment target
1
Study location

NCT07378865 is a Phase 1 study of Pain that is actively recruiting participants, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 12 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07378865, a Phase 1 study of Pain, is actively recruiting participants, sponsored by Vertex Pharmaceuticals Incorporated.

RECRUITING
Registry status
Phase 1
Development phase
12 participants
Enrollment target
1
Study location

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Suzetrigine

Study Locations (1)

Utah

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

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2026-02-13
Est. Completion 2027-02-26
Phase Phase 1

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

What the Registry Record Tells You About NCT07378865

The ClinicalTrials.gov registry entry for NCT07378865 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (96% lower). The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 1 intervention - of which Suzetrigine is the first listed.

NCT07378865 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.

Frequently Asked Questions

What is clinical trial NCT07378865 about?

NCT07378865 is a clinical study titled "Evaluation of the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Participants". 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 l...

What is the current status of trial NCT07378865?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2026-02-13. Estimated completion is 2027-02-26.

What conditions does trial NCT07378865 study?

This clinical trial studies the following conditions: Pain.

What interventions are being tested in trial NCT07378865?

The interventions under investigation include: Suzetrigine (DRUG).

Who is sponsoring clinical trial NCT07378865?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07378865 being conducted?

This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.