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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
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

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Billings Clinic, Pediatric Pulmonary Dept.
Coordinator of this site? Confirm its status
BillingsUnited StatesUnknown status
Boston Children's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Vermont Lung Center
Coordinator of this site? Confirm its status
ColchesterUnited StatesUnknown status
Cook Children's Pulmonology
Coordinator of this site? Confirm its status
Fort WorthUnited StatesUnknown status
New York Medical College
Coordinator of this site? Confirm its status
HawthorneUnited StatesUnknown status
Joe DiMaggio Cycstic Fibrosis & Pulmonary Center
Coordinator of this site? Confirm its status
HollywoodUnited StatesUnknown status
Kentucky Children's Hospital
Coordinator of this site? Confirm its status
LexingtonUnited StatesUnknown status
University of Minnesota -Pulmonology
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
AdventHealth Medical Group Pulmonology at Orlando Ridgewood
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Altasciences Clinical Kansas
Coordinator of this site? Confirm its status
Overland ParkUnited StatesUnknown status
University of Utah Hospital - Pulmonology
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status
ProMedica Toledo Children's Hospital & ProMedica Central Physicians, LLC
Coordinator of this site? Confirm its status
ToledoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.