Status:
RECRUITING
Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 health...
Detailed Description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 23 2026
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT06154447
Start Date
December 12 2023
End Date
April 23 2026
Last Update
December 4 2025
Active Locations (11)
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1
Joe DiMaggio Cycstic Fibrosis & Pulmonary Center
Hollywood, Florida, United States, 33021
2
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States, 32803
3
Altasciences Clinical Kansas
Overland Park, Kansas, United States, 66212
4
Kentucky Children's Hospital
Lexington, Kentucky, United States, 40508