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

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Vertex Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: VNZ/TEZ/D-IVA

Study type

Interventional

Funder types

Industry

Identifiers

NCT06299696
VX23-121-011

Details and patient eligibility

About

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.

Full 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.).

Enrollment

10 patients

Sex

All

Ages

25 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria may apply.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

VNZ/TEZ/D-IVA
Experimental group
Description:
Participants will be given VNZ/TEZ/D-IVA FDC to retain in their mouths for approximately 10 seconds and then expectorated.
Treatment:
Drug: VNZ/TEZ/D-IVA

Trial contacts and locations

1

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Central trial contact

Medical Information

Data sourced from clinicaltrials.gov

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