RECRUITINGPhase 1INTERVENTIONAL
Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis
A Phase 1, Study of VX-828 in Healthy Subjects and in Subjects With Cystic Fibrosis
About This Trial
The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics of VX-828 and VX-828 in triple combination (TC) with Tezacaftor (TEZ)/ VX-118 or TEZ/ deutivacaftor (D-IVA) in healthy participants and VX-828 in combination with D-IVA with or without TEZ in participants with cystic fibrosis (CF).
Who May Be Eligible (Plain English)
Key Who May Qualify:
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 current nonsmoking 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 a minimal function mutation that is not responsive to ELX/TEZ/IVA therapy
- Participants must have a forced expiratory volume in 1 second (FEV1) of greater than or equal to (≥) 40% of predicted normal for age, sex, and height
Key Who Should NOT Join This Trial:
Parts A-D:
- History of febrile illness or other acute illness within 14 days before the first dose 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 the first 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 pulmonary status
Other protocol defined Inclusion/Exclusion criteria will apply.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 current nonsmoking 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 a minimal function mutation that is not responsive to ELX/TEZ/IVA therapy
* Participants must have a forced expiratory volume in 1 second (FEV1) of greater than or equal to (≥) 40% of predicted normal for age, sex, and height
Key Exclusion Criteria:
Parts A-D:
* History of febrile illness or other acute illness within 14 days before the first dose 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 the first 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 pulmonary status
Other protocol defined Inclusion/Exclusion criteria will apply.
Treatments Being Tested
DRUG
VX-828
Suspension for Oral Administration
DRUG
Placebo
Suspension for Oral Administration
DRUG
Itraconazole
Solution for Oral Administration
DRUG
Midazolam
Syrup for Oral Administration
DRUG
Tezacaftor
Tablets for Oral Administration
DRUG
VX-118
Tablets for Oral Administration
DRUG
Placebo
Suspension and Tablets for Oral Administration
DRUG
Deutivacaftor
Tablets for Oral Administration
DRUG
VX-828
Tablets for Oral Administration
Locations (11)
Joe DiMaggio Cycstic Fibrosis & Pulmonary Center
Hollywood, Florida, United States
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States
Altasciences Clinical Kansas
Overland Park, Kansas, United States
Kentucky Children's Hospital
Lexington, Kentucky, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Minnesota -Pulmonology
Minneapolis, Minnesota, United States
New York Medical College
Hawthorne, New York, United States
ProMedica Toledo Children's Hospital & ProMedica Central Physicians, LLC
Toledo, Ohio, United States
Cook Children's Pulmonology
Fort Worth, Texas, United States
University of Utah Hospital - Pulmonology
Salt Lake City, Utah, United States
Vermont Lung Center
Colchester, Vermont, United States