Phase
Condition
Cystic Fibrosis
Scar Tissue
Lung Disease
Treatment
Itraconazole
VX-118
VX-828
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Parts A-D:
Participants between the ages of 18 and 55 years
Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)
A total body weight of more than (>) 50 kg
Nonsmoker or ex-smoker for at least 3 months before screening with currentnonsmoking status confirmed by urine or blood cotinine at screening
Cohort C2 only: Willing to provide a single DNA sample
Part E:
Participants 18 years or older
Confirmed diagnosis of CF as determined by the investigator
A total body weight of more than or equal to (>=) 35 kg
Participants must be heterozygous for F508del with a second CFTR allele carrying aminimal function mutation that is not responsive to ELX/TEZ/IVA therapy
Participants must have a forced expiratory volume in 1 second (FEV1) of greater thanor equal to (≥) 40% of predicted normal for age, sex, and height
Exclusion
Key Exclusion Criteria:
Parts A-D:
History of febrile illness or other acute illness within 14 days before the firstdose of study drug
Any condition possibly affecting drug absorption
Part E:
An acute illness not related to CF (e.g., gastroenteritis) within 14 days before thefirst dose of study drug
History of solid organ or hematological transplantation
History of clinically significant cirrhosis with or without portal hypertension
Lung infection with organisms associated with a more rapid decline in pulmonarystatus
Other protocol defined Inclusion/Exclusion criteria will apply.
Study Design
Study Description
Connect with a study center
Joe DiMaggio Cycstic Fibrosis & Pulmonary Center
Hollywood, Florida 33021
United StatesActive - Recruiting
AdventHealth Medical Group Pulmonology at Orlando Ridgewood
Orlando, Florida 32803
United StatesActive - Recruiting
Central Florida Pulmonary Group, P.A.
Orlando, Florida 32803
United StatesActive - Recruiting
Joe DiMaggio Cycstic Fibrosis & Pulmonary Center
Hollywood 4158928, Florida 4155751 33021
United StatesSite Not Available
Central Florida Pulmonary Group, P.A.
Orlando 4167147, Florida 4155751 32803
United StatesSite Not Available
Altasciences Clinical Kansas
Overland Park, Kansas 66212
United StatesCompleted
Altasciences Clinical Kansas
Overland Park 4276873, Kansas 4273857 66212
United StatesSite Not Available
Kentucky Children's Hospital
Lexington, Kentucky 40508
United StatesActive - Recruiting
Kentucky Children's Hospital
Lexington 4297983, Kentucky 6254925 40508
United StatesSite Not Available
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Boston Children's Hospital
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
University of Minnesota -Pulmonology
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
University of Minnesota -Pulmonology
Minneapolis 5037649, Minnesota 5037779 55455
United StatesSite Not Available
Billings Clinic, Pediatric Pulmonary Dept.
Billings, Montana 59101
United StatesActive - Recruiting
New York Medical College
Hawthorne, New York 10532
United StatesActive - Recruiting
New York Medical College
Hawthorne 5120284, New York 5128638 10532
United StatesSite Not Available
ProMedica Toledo Children's Hospital & ProMedica Central Physicians, LLC
Toledo, Ohio 43606
United StatesActive - Recruiting
ProMedica Toledo Children's Hospital & ProMedica Central Physicians, LLC
Toledo 5174035, Ohio 5165418 43606
United StatesSite Not Available
Cook Children's Pulmonology
Fort Worth, Texas 76104
United StatesActive - Recruiting
Cook Children's Pulmonology
Fort Worth 4691930, Texas 4736286 76104
United StatesSite Not Available
University of Utah Hospital - Pulmonology
Salt Lake City, Utah 84132
United StatesActive - Recruiting
University of Utah Hospital - Pulmonology
Salt Lake City 5780993, Utah 5549030 84132
United StatesSite Not Available
Vermont Lung Center
Colchester, Vermont 05446
United StatesActive - Recruiting
Vermont Lung Center
Colchester 5235024, Vermont 5242283 05446
United StatesSite Not Available

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