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A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis

NCT03911713 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2022-01-25

Study results available
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Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.

Conditions

Interventions

DRUG

VX-561

VX-561 tablets for oral administration.

DRUG

IVA

150-mg film-coated tablet for oral administration.

DRUG

Placebo

Placebo matched to IVA.

DRUG

Placebo

Placebos matched to VX-561.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2020-08-20
Completion
2020-08-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Germany
  • Ireland
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT03911713 on ClinicalTrials.gov