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Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation

NCT02589236 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2017-01-10

No results posted yet for this study

Summary

This will be a double-blind, randomized, placebo-controlled, parallel group study. The purpose of this study is to investigate the efficacy and safety of Cavosonstat (N91115) in adult patients with CF who are homozygous for the F508del-CFTR mutation and being treated with lumacaftor/ivacaftor (Orkambi™).

Conditions

Interventions

DRUG

Cavosonstat

GSNOR inhibitor

DRUG

Placebo

Control sample with only capsule excipients and fillers

Sponsors & Collaborators

  • Medidata Solutions

    collaborator INDUSTRY

  • Nivalis Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Scott Donaldson, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02589236 on ClinicalTrials.gov