NCT02589236

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 to Evaluate Efficacy and Safety in Patients With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation Treated With Lumacaftor/Ivacaftor

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Nivalis Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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™).

Detailed description

Primary Objective: * Assess the efficacy of N91115 at 12 weeks when added to preexisting treatment with lumacaftor/ivacaftor in adult patients with CF who are homozygous for the F508del-CFTR mutation Secondary Objectives: * Assess the effect of N91115 added to lumacaftor/ivacaftor on safety * Assess the effect of lumacaftor/ivacaftor added to N91115 on the pharmacokinetics of N91115, lumacaftor, and ivacaftor

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Cavosonstat	GSNOR inhibitor
DRUG	Placebo	Control sample with only capsule excipients and fillers

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-10-28
• Last updated: 2017-01-10

Locations

46 sites across 1 country: United States