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Completed Phase 1Phase 2 Interventional Accepts healthy volunteers Results available

A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis

ClinicalTrials.gov ID: NCT03227471

Public ClinicalTrials.gov record NCT03227471. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:43 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).

Study identification

NCT ID
NCT03227471
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
225 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 22, 2017
Primary completion
Mar 26, 2018
Completion
Mar 26, 2018
Last update posted
Jan 17, 2022

2017 – 2018

United States locations

U.S. sites
26
U.S. states
19
U.S. cities
26
Facility City State ZIP Site status
Banner University of Arizona Medical Center Tucson Arizona 85724
University of Arkansas for Medical Sciences Little Rock Arkansas 72205
Valley Children's Healthcare Madera California 93636
(Kaiser Permanente) Oakland Medical Center Oakland California 96411
National Jewish Health Denver Colorado 80206
Central Florida Pulmonary Group Orlando Florida 32803
Tampa General Hospital Cardiac and Lung Transplant Clinic Tampa Florida 33606
Children's Specialty Services at North Druid Hills Atlanta Georgia 30324
Northwestern Memorial Hospital Chicago Illinois 60611
Covance Clinical Research Unit Inc., Evansville Clinic [Parts A, B, C only] Evansville Indiana 47710
University of Kansas Medical Center Kansas City Kansas 66160
Tulane Medical Center New Orleans Louisiana 70112
Harper University Hospital Detroit Michigan 48201
Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minn Minneapolis Minnesota 55404
Morristown Medical Center Morristown New Jersey 07960
University of New Mexico School of Medicine Albuquerque New Mexico 87131
UC Health Office of Clinical Research Cincinnati Ohio 45267
University Hospitals Cleveland Medical Center/Rainbow Babies and Children's Hospital Cleveland Ohio 44106
Nationwide Children's Hospital Columbus Ohio 43205
Austin Children's Chest Associates Austin Texas 78723
The University of Vermont Burlington Vermont 05401
University of Virginia Health System Charlottesville Virginia 22908
West Virginia University Hospitals Morgantown Virginia 26506
Children's Hospital of the King's Daughters Norfolk Virginia 23507
Virginia Commonwealth University Richmond Virginia 23298
Medical College of Wisconsin Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03227471, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 17, 2022 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03227471 live on ClinicalTrials.gov.

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