Overview

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)

Status:
Completed

Trial end date:
2018-09-01

Target enrollment:

Participant gender:

Summary

This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the pharmacokinetic (PK), safety, and tolerability of multiple doses of tezacaftor (TEZ) in combination with ivacaftor (IVA) in subjects 6 through 11 years of age with CF who are homozygous or heterozygous for the F508del- CF transmembrane conductance regulator protein (CFTR) mutation.

Phase:

Phase 3

Details

Lead Sponsor:

Vertex Pharmaceuticals Incorporated

Treatments:

Ivacaftor