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

NCT06154447 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2026-04-14

No results posted yet for this 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)/ 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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2026-04-23
Completion
2026-04-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06154447 on ClinicalTrials.gov