A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists
Phase 1
Completed
- Conditions
- Cystic Fibrosis
- Interventions
- Drug: VNZ/TEZ/D-IVA
- Registration Number
- NCT06299696
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- 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.).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VNZ/TEZ/D-IVA VNZ/TEZ/D-IVA Participants will be given VNZ/TEZ/D-IVA FDC to retain in their mouths for approximately 10 seconds and then expectorated.
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Site 001
🇺🇸Woburn, Massachusetts, United States