A Study of Suzetrigine (SUZ) Spray-dried Dispersion (SSD) in Healthy Adult Panelists

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: SUZ

• Registration Number: NCT06834009
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

The purpose of this study is to evaluate the sensory attributes (basic tastes, aroma, texture, mouthfeel) of SUZ SDD and assess the impact of the dose on the sensory attributes.

Detailed Description

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.).

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-13
• Study First Posted: 2025-02-19
• Study Start: 2025-03-10
• Primary Completion: 2025-04-24
• Study Completion: 2025-04-24
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Panelists are qualified based on training and experience. They will be required to detect, identify, recognize, and accurately describe different taste elements and flavor combinations.

Key

Exclusion Criteria

• History of any illness or clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant
• Sensitivity to SUZ
• Pregnant, nursing, or planning to become pregnant during the study

Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SUZ	SUZ	Participants will be given SUZ SDD to retain in their mouths for approximately 10 seconds and then expectorate.

Primary Outcome Measures

Name	Time	Method
Flavor Assessment Based on Flavor Profile Method of Descriptive Sensory Analysis per American Society for Testing and Material (ASTM) Approved Sensory Evaluation Method	Periodic Intervals up to 30 minutes post oral administration

Trial Locations

Locations (1)

Senopsys, LLC; 🇺🇸 Woburn, Massachusetts, United States