Actively Recruiting
Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis
Led by Vertex Pharmaceuticals Incorporated · Updated on 2026-04-14
255
Participants Needed
12
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 55 years for Parts A-D
- Body mass index between 18.0 and 32.0 kg/m2 for Parts A-D
- Body weight over 50 kg for Parts A-D
- Current nonsmoking status or ex-smoker for at least 3 months for Parts A-D
- Willingness to provide a DNA sample for Cohort C2
- Participants 18 years or older with confirmed cystic fibrosis for Part E
- Body weight 35 kg or more for Part E
- Heterozygous for F508del with a second CFTR allele carrying a minimal function mutation not responsive to ELX/TEZ/IVA therapy for Part E
- Forced expiratory volume in 1 second (FEV1) 40% or higher of predicted normal for age, sex, and height for Part E
You will not qualify if you...
- History of febrile illness or acute illness within 14 days before first dose for Parts A-D
- Any condition affecting drug absorption for Parts A-D
- Acute illness not related to cystic fibrosis within 14 days before first dose for Part E
- History of solid organ or blood transplantation for Part E
- History of clinically significant liver cirrhosis with or without portal hypertension for Part E
- Lung infection with organisms linked to faster decline in lung function for Part E
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Joe DiMaggio Cycstic Fibrosis & Pulmonary Center
Hollywood, Florida, United States, 33021
Actively Recruiting
2
AdventHealth Medical Group Pulmonology at Orlando Ridgewood
Orlando, Florida, United States, 32803
Actively Recruiting
3
Altasciences Clinical Kansas
Overland Park, Kansas, United States, 66212
Completed
4
Kentucky Children's Hospital
Lexington, Kentucky, United States, 40508
Actively Recruiting
5
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
University of Minnesota -Pulmonology
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
7
Billings Clinic, Pediatric Pulmonary Dept.
Billings, Montana, United States, 59101
Actively Recruiting
8
New York Medical College
Hawthorne, New York, United States, 10532
Actively Recruiting
9
ProMedica Toledo Children's Hospital & ProMedica Central Physicians, LLC
Toledo, Ohio, United States, 43606
Actively Recruiting
10
Cook Children's Pulmonology
Fort Worth, Texas, United States, 76104
Actively Recruiting
11
University of Utah Hospital - Pulmonology
Salt Lake City, Utah, United States, 84132
Actively Recruiting
12
Vermont Lung Center
Colchester, Vermont, United States, 05446
Actively Recruiting
Research Team
M
Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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