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

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

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.).

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.