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



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:January 23, 2017
End Date:March 27, 2018

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

This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts.
Parts A, B, and C will be conducted in healthy subjects. Parts D, E, and F will be 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).


Key Inclusion Criteria:

Parts A, B, and C:

- Female subjects must be of non-childbearing potential.

- Between the ages of 18 and 55 years, inclusive.

- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight >50 kg

Parts D, E, and F:

- Body weight ≥35 kg.

- Subjects must have an eligible CFTR genotype:

- Parts D and F: Heterozygous for F508del and an MF mutation (F/MF)

- Part E: Homozygous for F508del (F/F)

- FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height.

Key Exclusion Criteria:

Parts A, B, and C:

- Any condition possibly affecting drug absorption.

- History of febrile illness within 14 days before the first study drug dose.

- Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Parts D, E, and F:

- History of clinically significant cirrhosis with or without portal hypertension.

- Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

- Lung infection with organisms associated with a more rapid decline in pulmonary
status.

- History of solid organ or hematological transplantation.

Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
27
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1605 Chantilly Drive Northeast
Atlanta, Georgia 30324
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85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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326 North Mills Avenue
Orlando, Florida 32803
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Albuquerque, NM
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Austin, TX
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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Cincinnati, Ohio 45267
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246 Clayton Road
Clayton, Victoria 3168
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Detroit, Michigan 48201
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Madera, California 93636
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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1 Medical Center Drive
Morgantown, Virginia 26506
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Morristown, New Jersey 07962
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New Orleans, Louisiana 70112
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Oakland, California 94611
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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1 Tampa General Circle
Tampa, Florida 33606
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