NCT03227471

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

A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

• Cystic Fibrosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-01-23
• Primary completion: 2018-03-27
• Completion: 2018-03-27
• First posted: 2017-07-24
• Last updated: 2022-01-18
• Results posted: 2022-01-18

Locations

38 sites across 4 countries: United States, Australia, Belgium, Netherlands

Regulatory

• FDA-regulated drug study