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NCT06299696 Clinical Trial

A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists

Cystic Fibrosis Clinical Trial

Official title:
A Phase 1, Open-label Taste Assessment Study of Vanzacaftor/Tezacaftor/Deutivacaftor in Healthy Adult Panelists

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06299696
Other study ID # VX23-121-011
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 26, 2024
Est. completion date April 16, 2024

Study information
Verified date May 2024
Source Vertex Pharmaceuticals Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the flavor (basic tastes, aroma, texture, mouthfeel) of VNZ/TEZ/D-IVA fixed dose combination (FDC) granules.

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.).

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date April 16, 2024
Est. primary completion date April 16, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 80 Years
Eligibility Key Inclusion Criteria: - Panelists are trained 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 VNZ, TEZ, or D-IVA. - Pregnant, nursing, or planning to become pregnant during the study Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• VNZ/TEZ/D-IVA
FDC granules for oral administration

Locations
Country Name City State
United States Site 001 Woburn Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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