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

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).

Conditions

Cystic Fibrosis
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Related Conditions:

Cystic Fibrosis

Study Overview

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Study Details

Study overview

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).

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

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

Condition
Cystic Fibrosis
Intervention / Treatment

-

Contacts and Locations

Overland Park

Altasciences Clinical Kansas, Overland Park, Kansas, United States, 66212

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * History of febrile illness or other acute illness within 14 days before the first dose of study drug
  • * Any condition possibly affecting drug absorption
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Vertex Pharmaceuticals Incorporated,

Study Record Dates

2026-02-05