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Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age

NCT03633526 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-02-05

Study results available
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Summary

This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-659, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects with F/F or F/MF genotypes.

The study was discontinued after completion of Part A due to Sponsor's discretion.

Conditions

Interventions

DRUG

VX-659/TEZ/IVA

VX-659/TEZ/IVA FDC tablet.

DRUG

IVA

IVA mono tablet.

Sponsors & Collaborators

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-03
Primary Completion
2019-01-18
Completion
2019-01-18
FDA Drug
Yes

Countries

  • United States

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 NCT03633526 on ClinicalTrials.gov