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NCT06154447 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.

Recruiting
Registry status
Phase 1
Development phase
255
Enrollment target
11
Study locations

NCT06154447 is a Phase 1 study of Cystic Fibrosis that is actively recruiting participants, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 255 participants, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (43% higher). The trial reports 11 study locations across 10 states.

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The verdict

NCT06154447, a Phase 1 study of Cystic Fibrosis, is actively recruiting participants, sponsored by Vertex Pharmaceuticals Incorporated.

RECRUITING
Registry status
Phase 1
Development phase
255 participants
Enrollment target
11
Study locations

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 Studied

Cystic Fibrosis

Interventions

  • DRUG Placebo
  • DRUG Midazolam
  • DRUG Itraconazole
  • DRUG VX-828
  • DRUG Tezacaftor

Study Locations (11)

Florida

  • Joe DiMaggio Cycstic Fibrosis & Pulmonary Center - Hollywood
  • Central Florida Pulmonary Group, P.A. - Orlando

Kansas

  • Altasciences Clinical Kansas - Overland Park

Kentucky

  • Kentucky Children's Hospital - Lexington

Massachusetts

  • Boston Children's Hospital - Boston

Minnesota

  • University of Minnesota -Pulmonology - Minneapolis

New York

  • New York Medical College - Hawthorne

Ohio

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

Texas

  • Cook Children's Pulmonology - Fort Worth

Trial Details

FieldValue
Enrollment Target 255 participants
Start Date 2023-12-12
Est. Completion 2026-04-23
Phase Phase 1

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

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What the Registry Record Tells You About NCT06154447

The ClinicalTrials.gov registry entry for NCT06154447 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 255 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (43% higher). The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.

NCT06154447 reports 11 study locations spanning 10 distinct geographic areas - top geographies include Florida, Kansas, Kentucky.

Frequently Asked Questions

What is clinical trial NCT06154447 about?

NCT06154447 is a clinical study titled "Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis". 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 ...

What is the current status of trial NCT06154447?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 255 participants. The study started on 2023-12-12. Estimated completion is 2026-04-23.

What conditions does trial NCT06154447 study?

This clinical trial studies the following conditions: Cystic Fibrosis.

What interventions are being tested in trial NCT06154447?

The interventions under investigation include: Placebo (DRUG), Midazolam (DRUG), Itraconazole (DRUG), VX-828 (DRUG), Tezacaftor (DRUG).

Who is sponsoring clinical trial NCT06154447?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06154447 being conducted?

This trial has 11 study locations across Florida, Kansas, Kentucky, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.