NCT06299696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 29, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

March 26, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

21 days

First QC Date

February 29, 2024

Last Update Submit

May 15, 2024

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

VNZ/TEZ/D-IVA

EXPERIMENTAL

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

Drug: VNZ/TEZ/D-IVA

Interventions

VNZ/TEZ/D-IVADRUG

FDC granules for oral administration

Also known as: VX-121/VX-661/CTP-656, VX-121/VX-661/VX-561, Vanzacaftor/tezacaftor/deutivacaftor
VNZ/TEZ/D-IVA

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 001

Woburn, Massachusetts, 01801, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

deutivacaftor, tezacaftor , vanzacaftor

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 8, 2024

Study Start

March 26, 2024

Primary Completion

April 16, 2024

Study Completion

April 16, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Locations

US(1)