Cystic Fibrosis
Conditions
Brief 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.
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.).
Interventions
DRUGVNZ/TEZ/D-IVA
FDC granules for oral administration
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed