Phase
Condition
Cystic Fibrosis
Scar Tissue
Lung Disease
Treatment
Itraconazole
VX-828
Placebo
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Parts A-D:
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
Part E:
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
Altasciences Clinical Kansas
Overland Park, Kansas 66212
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.