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RECRUITING
NCT06154447
PHASE1

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

Sponsor: Vertex Pharmaceuticals Incorporated

View on ClinicalTrials.gov

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)/ 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

255

Start Date

2023-12-12

Completion Date

2026-04-23

Last Updated

2026-03-27

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

VX-828

Suspension for Oral Administration

DRUG

Placebo

Suspension for Oral Administration

DRUG

Itraconazole

Solution for Oral Administration

DRUG

Midazolam

Syrup for Oral Administration

DRUG

Tezacaftor

Tablets for Oral Administration

DRUG

VX-118

Tablets for Oral Administration

DRUG

Placebo

Suspension and Tablets for Oral Administration

DRUG

Deutivacaftor

Tablets for Oral Administration

DRUG

VX-828

Tablets for Oral Administration

Locations (11)

Joe DiMaggio Cycstic Fibrosis & Pulmonary Center

Hollywood, Florida, United States

Central Florida Pulmonary Group, P.A.

Orlando, Florida, United States

Altasciences Clinical Kansas

Overland Park, Kansas, United States

Kentucky Children's Hospital

Lexington, Kentucky, United States

Boston Children's Hospital

Boston, Massachusetts, United States

University of Minnesota -Pulmonology

Minneapolis, Minnesota, United States

New York Medical College

Hawthorne, New York, United States

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

Toledo, Ohio, United States

Cook Children's Pulmonology

Fort Worth, Texas, United States

University of Utah Hospital - Pulmonology

Salt Lake City, Utah, United States

Vermont Lung Center

Colchester, Vermont, United States