NCT06834009

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 pain

Timeline
Completed

Started Mar 2025

Shorter than P25 for phase_1 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2025

Completed
Last Updated

May 14, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

February 13, 2025

Last Update Submit

May 9, 2025

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

SUZ

EXPERIMENTAL

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

Drug: SUZ

Interventions

SUZDRUG

Powder for oral administration.

Also known as: VX-548
SUZ

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Senopsys, LLC

Woburn, Massachusetts, 01801, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 19, 2025

Study Start

March 10, 2025

Primary Completion

April 24, 2025

Study Completion

April 24, 2025

Last Updated

May 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Locations

US(1)