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

Vertex Pharmaceuticals Incorporated10 enrolled

Overview

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.

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.).

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

VNZ/TEZ/D-IVADRUG

FDC granules for oral administration

Eligibility

Sex: ALLMin age: 25 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Site 001

Woburn, Massachusetts, United States

Outcomes

Primary Outcomes

Flavor Assessment Based on Flavor Profile Method of Descriptive Sensory Analysis per American Society for Testing and Material (ASTM) Approved Sensory Evaluation Method

Time frame: Periodic Intervals up to 30 minutes post oral administration

Data from ClinicalTrials.gov

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