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

Last updated: January 16, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Recruiting

Phase

1

Condition

Cystic Fibrosis

Scar Tissue

Lung Disease

Treatment

Itraconazole

VX-828

Placebo

Clinical Study ID

NCT06154447
VX23-828-001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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) and VX-118 in healthy participants and in participants with cystic fibrosis (CF).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

Parts A-D:

  • 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 currentnonsmoking status confirmed by urine or blood cotinine at screening

Part E:

  • 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 aminimal function mutation that is not responsive to ELX/TEZ/IVA therapy

  • Participants must have a forced expiratory volume in 1 second (FEV1) of greater thanor equal to (≥) 40% of predicted normal for age, sex, and height

Exclusion

Key Exclusion Criteria:

Parts A-D:

  • History of febrile illness or other acute illness within 14 days before the firstdose 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 thefirst 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 pulmonarystatus

Other protocol defined Inclusion/Exclusion criteria will apply.

Study Design

Total Participants: 225
Treatment Group(s): 6
Primary Treatment: Itraconazole
Phase: 1
Study Start date:
December 12, 2023
Estimated Completion Date:
December 31, 2025

Study Description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Connect with a study center

  • Altasciences Clinical Kansas

    Overland Park, Kansas 66212
    United States

    Active - Recruiting

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