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CFTR Modulator

Group 1 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 between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 11 and 21

Awards & highlights

Study Summary

This trial tests the safety, effectiveness and how drugs are used in the body of healthy people taking a new medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 11 and 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 11 and 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 11 and 21 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in QT interval corrected by Fridericia's formula (QTcF)

Secondary outcome measures

Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to 24 hours (AUC0-24h)) of VNZ

Change in Heart Rate (HR)

Change in PR interval, segment

+13 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group 1Experimental Treatment3 Interventions

Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and VNZ at different time points.

Group II: Group 2BActive Control3 Interventions

Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.

Group III: Group 2AActive Control3 Interventions

Participants will receive VNZ-matching placebo, moxifloxacin, and moxifloxacin-matching placebo at different time points.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vanzacaftor

2023

Completed Phase 1

~60

Vanzacaftor Placebo

2023

Completed Phase 1

~60

Moxifloxacin Placebo

2012

Completed Phase 3

~1400

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

243 Previous Clinical Trials

32,331 Total Patients Enrolled

126 Trials studying Cystic Fibrosis

17,693 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.

Are there potential hazards associated with Group 1 medications?

"Because Group 1 is in Phase 1 of its clinical trial, the safety score given by Power was a conservative one (1), due to limited evidence supporting both efficacy and safety."

Answered by AI

How many participants can partake in the clinical trial?

"Correct. Information on clinicaltrials.gov verifies that this trial is presently recruiting patients; it was initially published on April 26th 2023 and amended most recently on May 16th of the same year. A total of 56 individuals will be admitted from one medical centre."

Answered by AI

Does this research endeavor permit individuals over the age of twenty to participate?

"Patients aged 18 to 45 are the only ones eligible for this research project. In contrast, there are 70 and 93 trials available respectively for individuals below 18 or above 65 years of age."

Answered by AI

Who would qualify as an ideal participant for this clinical trial?

"This research endeavor is searching for 56 individuals with cystic fibrosis, aged between 18 and 45. Those who fulfill the requirements will be eligible to join the trial."

Answered by AI

Are there any vacancies in this clinical trial available for prospective participants?

"Yes, the information on clinicaltrials.gov confirms that this research is actively accepting participants. This trial was originally posted on April 26th 2023 and updated most recently on May 16th 2023. Researchers are seeking 56 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Electrocardiogram Study to Evaluate the Effect of Vanzacaftor on the QT/QTc Interval in Healthy Participants

2023. "An Electrocardiogram Study to Evaluate the Effect of Vanzacaftor on the QT/QTc Interval in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05867147.