RECRUITING

Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis

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Conditions

Cystic Fibrosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1, Study of VX-828 in Healthy Subjects and in Subjects With Cystic Fibrosis

Quick Facts

Study Start:2023-12-12
Study Completion:2026-02-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06154447

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants between the ages of 18 and 55 years
  2. * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
  3. * A total body weight of more than (\>) 50 kg
  4. * Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening
  5. * Cohort C2 only: Willing to provide a single DNA sample
  6. * Participants 18 years or older
  7. * Confirmed diagnosis of CF as determined by the investigator
  8. * A total body weight of more than or equal to (\>=) 35 kg
  9. * 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
  10. * 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
  1. * History of febrile illness or other acute illness within 14 days before the first dose of study drug
  2. * Any condition possibly affecting drug absorption
  3. * An acute illness not related to CF (e.g., gastroenteritis) within 14 days before the first dose of study drug
  4. * History of solid organ or hematological transplantation
  5. * History of clinically significant cirrhosis with or without portal hypertension
  6. * Lung infection with organisms associated with a more rapid decline in pulmonary status

Contacts and Locations

Study Contact

Medical Information
CONTACT
617-341-6777
medicalinfo@vrtx.com

Study Locations (Sites)

Altasciences Clinical Kansas
Overland Park, Kansas, 66212
United States

Collaborators and Investigators

Sponsor: Vertex Pharmaceuticals Incorporated

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-12
Study Completion Date2026-02-05

Study Record Updates

Study Start Date2023-12-12
Study Completion Date2026-02-05

Terms related to this study

Additional Relevant MeSH Terms

  • Cystic Fibrosis