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

NCT ID: NCT06154447

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-12

Study Completion Date

2026-04-23

Brief Summary

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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).

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Detailed Description

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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.).

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: Single Ascending Dose (SAD)

Participants will be randomized to receive a single dose of different dose levels of VX-828.

Group Type EXPERIMENTAL

VX-828

Intervention Type DRUG

Suspension for Oral Administration

Part A: Placebo

Participants will be randomized to receive placebo matched to VX-828.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Suspension for Oral Administration

Part B: Multiple Ascending Dose (MAD)

Participants will be randomized to receive multiple doses of different dose levels of VX-828. The dose levels will be determined based on the data from Part A.

Group Type EXPERIMENTAL

VX-828

Intervention Type DRUG

Suspension for Oral Administration

Part B: Placebo

Participants will be randomized to receive placebo matched to VX-828.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Suspension for Oral Administration

Part C: Drug Drug Interaction

Participants will receive a single dose of VX-828, followed by a washout period, Itraconazole administration, and concomitant administration of itraconazole and VX-828; or participants will receive Midazolam followed by VX-828/TEZ/D-IVA administration, and concomitant administration of VX-828/TEZ/D-IVA and Midazolam.

Part C will be an open-label optional cohort.

Group Type EXPERIMENTAL

VX-828

Intervention Type DRUG

Suspension for Oral Administration

Itraconazole

Intervention Type DRUG

Solution for Oral Administration

Midazolam

Intervention Type DRUG

Syrup for Oral Administration

Tezacaftor

Intervention Type DRUG

Tablets for Oral Administration

Deutivacaftor

Intervention Type DRUG

Tablets for Oral Administration

Part D: VX-828 in combination with TEZ/VX-118 ,TEZ/D-IVA or D-IVA

Participants will be randomized to receive VX-828 in combination with TEZ/VX-118, TEZ/D-IVA, or D-IVA.

Group Type EXPERIMENTAL

VX-828

Intervention Type DRUG

Suspension for Oral Administration

Tezacaftor

Intervention Type DRUG

Tablets for Oral Administration

VX-118

Intervention Type DRUG

Tablets for Oral Administration

Deutivacaftor

Intervention Type DRUG

Tablets for Oral Administration

Part D: Placebo

Participants will be randomized to receive placebo matched to VX-828/TEZ/VX-118 or placebo matched to VX-828 in combination with TEZ/D-IVA or D-IVA

Group Type PLACEBO_COMPARATOR

Tezacaftor

Intervention Type DRUG

Tablets for Oral Administration

Placebo

Intervention Type DRUG

Suspension and Tablets for Oral Administration

Deutivacaftor

Intervention Type DRUG

Tablets for Oral Administration

Part E: VX-828 in Combination with D-IVA with or without TEZ in CF

Participants with cystic fibrosis will receive VX-828 in combination with D-IVA with or without TEZ.

Group Type EXPERIMENTAL

Tezacaftor

Intervention Type DRUG

Tablets for Oral Administration

Deutivacaftor

Intervention Type DRUG

Tablets for Oral Administration

VX-828

Intervention Type DRUG

Tablets for Oral Administration

Interventions

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VX-828

Suspension for Oral Administration

Intervention Type DRUG

Placebo

Suspension for Oral Administration

Intervention Type DRUG

Itraconazole

Solution for Oral Administration

Intervention Type DRUG

Midazolam

Syrup for Oral Administration

Intervention Type DRUG

Tezacaftor

Tablets for Oral Administration

Intervention Type DRUG

VX-118

Tablets for Oral Administration

Intervention Type DRUG

Placebo

Suspension and Tablets for Oral Administration

Intervention Type DRUG

Deutivacaftor

Tablets for Oral Administration

Intervention Type DRUG

VX-828

Tablets for Oral Administration

Intervention Type DRUG

Other Intervention Names

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TEZ VX-661 D-IVA VX-561

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Joe DiMaggio Cycstic Fibrosis & Pulmonary Center

Hollywood, Florida, United States

Site Status RECRUITING

Central Florida Pulmonary Group, P.A.

Orlando, Florida, United States

Site Status RECRUITING

Altasciences Clinical Kansas

Overland Park, Kansas, United States

Site Status RECRUITING

Kentucky Children's Hospital

Lexington, Kentucky, United States

Site Status RECRUITING

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

University of Minnesota -Pulmonology

Minneapolis, Minnesota, United States

Site Status RECRUITING

New York Medical College

Hawthorne, New York, United States

Site Status RECRUITING

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

Toledo, Ohio, United States

Site Status RECRUITING

Cook Children's Pulmonology

Fort Worth, Texas, United States

Site Status RECRUITING

University of Utah Hospital - Pulmonology

Salt Lake City, Utah, United States

Site Status RECRUITING

Vermont Lung Center

Colchester, Vermont, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Medical Information

Role: CONTACT

[email protected]
617-341-6777

Other Identifiers

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VX23-828-001

Identifier Type: -

Identifier Source: org_study_id

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