NCT06154447CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 165 (actual)
- First submitted
- 23 Nov 2023
- Start date
- 12 Dec 2023
- Primary completion date
- 10 Jul 2026
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Diseases
- Cystic fibrosis
- NCT number
- NCT06154447
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 165
- From 12 Dec 2023 to the primary completion date, 10 Jul 2026
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of febrile illness or other acute illness within 14 days before the first dose of study drug
- An acute illness not related to CF (e.g., gastroenteritis) within 14 days before the first dose of study drug
Other illness
- Any condition possibly affecting drug absorption
- Part E:
- 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.
Other
- Parts A-D:
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Billings Clinic, Pediatric Pulmonary Dept. Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Vermont Lung Center Coordinator of this site? Confirm its status | Colchester | United States | Unknown status |
| Cook Children's Pulmonology Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| New York Medical College Coordinator of this site? Confirm its status | Hawthorne | United States | Unknown status |
| Joe DiMaggio Cycstic Fibrosis & Pulmonary Center Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Kentucky Children's Hospital Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| University of Minnesota -Pulmonology Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| AdventHealth Medical Group Pulmonology at Orlando Ridgewood Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Altasciences Clinical Kansas Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| University of Utah Hospital - Pulmonology Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| ProMedica Toledo Children's Hospital & ProMedica Central Physicians, LLC Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.