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VNZ/TEZ/D-IVA for Cystic Fibrosis

Phase 1

Waitlist Available

Research Sponsored by Vertex Pharmaceuticals Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up periodic intervals up to 30 minutes post oral administration

Awards & highlights

Study Summary

This trial aims to test how the combination of VNZ, TEZ, and D-IVA in granule form tastes and feels in the mouth.

Who is the study for?

This trial is for healthy adults who are trained in detecting and describing different taste elements. They must not have any illnesses that could affect the study results or be sensitive to VNZ, TEZ, or D-IVA. Pregnant or nursing individuals, or those planning pregnancy during the study cannot participate.Check my eligibility

What is being tested?

The trial is testing a combination of drugs called Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) specifically for their flavor profile which includes basic tastes, aroma, texture, and mouthfeel when taken as granules.See study design

What are the potential side effects?

Since this trial focuses on flavor evaluation by healthy participants rather than therapeutic effects, specific side effects are not detailed; however standard risks associated with clinical trials still apply.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ periodic intervals up to 30 minutes post oral administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~periodic intervals up to 30 minutes post oral administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and periodic intervals up to 30 minutes post oral administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: VNZ/TEZ/D-IVAExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor

245 Previous Clinical Trials

32,530 Total Patients Enrolled

126 Trials studying Cystic Fibrosis

17,740 Patients Enrolled for Cystic Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the process of enrolling participants currently underway for this clinical trial?

"As per the details on clinicaltrials.gov, this specific research endeavor is not presently seeking participants. Originally shared on March 26th, 2024 and last revised on April 5th, 2024; it's currently inactive in terms of patient recruitment. Nonetheless, it's worth noting that there are numerous other studies – a total of 113 – actively enrolling subjects at present."

Answered by AI

Can individuals younger than 18 years old participate in this research investigation?

"Individuals seeking to participate in this research must be between 25 and 80 years old."

Answered by AI

Has the combination of VNZ, TEZ, and D-IVA received approval from the FDA?

"In light of this being a Phase 1 trial with minimal data backing its safety and efficacy, the team at Power has rated VNZ/TEZ/D-IVA as 1 on our scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06299696.