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 |
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).
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
sites
601 Children's Lane
Norfolk, Virginia 23507
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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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
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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1605 Chantilly Drive Northeast
Atlanta, Georgia 30324
Atlanta, Georgia 30324
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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11100 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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617 Oakley Street
Evansville, Indiana 47710
Evansville, Indiana 47710
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minn
2530 Chicago Avenue
Minneapolis, Minnesota 55404
Minneapolis, Minnesota 55404
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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
Tampa, Florida 33606
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