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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: SUZ

Study type: Interventional

Funder types: Industry

Identifiers

NCT06834009

VX24-548-020

Details and patient eligibility

About

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.

Full 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.).

Enrollment: 10 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

SUZ

Experimental group

Description:

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

Treatment:

Drug: SUZ