Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New CF drug combo VX-828 enters early human testing

NCT ID NCT06154447

Disease control Sponsor: Vertex Pharmaceuticals Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This early-stage study tests the safety and how the body handles a new drug called VX-828, alone or combined with other CF medicines. It involves about 165 healthy adults and people with cystic fibrosis. The goal is to see if VX-828 is safe enough for further testing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

165 people

The number who actually took part.

Started

Dec 2023

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cystic fibrosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis

Contacts and locations

Locations

  • AdventHealth Medical Group Pulmonology at Orlando Ridgewood

    Orlando, Florida, 32803, United States

  • Altasciences Clinical Kansas

    Overland Park, Kansas, 66212, United States

  • Billings Clinic, Pediatric Pulmonary Dept.

    Billings, Montana, 59101, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Cook Children's Pulmonology

    Fort Worth, Texas, 76104, United States

  • Joe DiMaggio Cycstic Fibrosis & Pulmonary Center

    Hollywood, Florida, 33021, United States

  • Kentucky Children's Hospital

    Lexington, Kentucky, 40508, United States

  • New York Medical College

    Hawthorne, New York, 10532, United States

  • ProMedica Toledo Children's Hospital & ProMedica Central Physicians, LLC

    Toledo, Ohio, 43606, United States

  • University of Minnesota -Pulmonology

    Minneapolis, Minnesota, 55455, United States

  • University of Utah Hospital - Pulmonology

    Salt Lake City, Utah, 84132, United States

  • Vermont Lung Center

    Colchester, Vermont, 05446, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.