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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-26

Study Completion Date

2024-04-16

Brief Summary

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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.

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Detailed Description

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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.).

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

VNZ/TEZ/D-IVA

Intervention Type DRUG

FDC granules for oral administration

Interventions

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VNZ/TEZ/D-IVA

FDC granules for oral administration

Intervention Type DRUG

Other Intervention Names

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VX-121/VX-661/CTP-656 VX-121/VX-661/VX-561 Vanzacaftor/tezacaftor/deutivacaftor

Eligibility Criteria

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Inclusion Criteria

* Panelists are trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations.

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes