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A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis

NCT03227471 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2022-01-18

Study results available
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Summary

This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).

Conditions

Interventions

DRUG

IVA

IVA tablet for oral administration

DRUG

TEZ/IVA

TEZ/IVA fixed-dose combination for oral administration.

DRUG

VX-445

VX-445 tablet for oral administration.

DRUG

Matched Placebo

Matched placebo.

DRUG

TEZ

Tablet for oral administration.

DRUG

VX-561

Tablet for oral administration.

DRUG

VX-445

VX-445 IV injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-23
Primary Completion
2018-03-27
Completion
2018-03-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

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 NCT03227471 on ClinicalTrials.gov