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Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation (SNO-6)

This study has been completed.
Sponsor:
Collaborator:
Medidata Solutions
Information provided by (Responsible Party):
Nivalis Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02589236
First received: October 26, 2015
Last updated: January 6, 2017
Last verified: January 2017
October 26, 2015
January 6, 2017
November 2015
December 2016   (Final data collection date for primary outcome measure)
Absolute change from baseline in percent predicted FEV1 (ppFEV1) [ Time Frame: From baseline to 12 weeks ]
Forced Expiratory Volume in one second (FEV1) from before study (Baseline) to after 12 weeks of N91115 treatment
Same as current
Complete list of historical versions of study NCT02589236 on ClinicalTrials.gov Archive Site
  • Relative change from baseline in ppFEV1 [ Time Frame: baseline to 12 weeks ]
    Forced Expiratory Volume in one second (FEV1) from before study (Baseline) to after 12 weeks of N91115 treatment
  • Absolute change from baseline in sweat chloride [ Time Frame: baseline to 12 weeks ]
    A sweat chloride measurement on the skin at study start and after 12 weeks of N91115
  • Absolute change from baseline in Cystic Fibrosis Questionnaire -Revised CFQ-R (respiratory symptom scale) [ Time Frame: baseline to 16 weeks ]
    Comparison of the Questionnaire from study start to 16 weeks
  • Absolute change from baseline in body mass index (BMI) [ Time Frame: baseline to 12 weeks ]
    Assessment of change in body mass index from study start to after 12 weeks of N91115
  • Absolute change from baseline in Patient Global Impression of Change (PGIC) [ Time Frame: baseline to 12 weeks ]
    Patient reported outcome journal
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) [ Time Frame: baseline to 16 weeks ]
    Any adverse events assessment including clinical laboratory values, electrocardiogram (ECG), pulmonary exacerbations, or vital sign changes
  • Pharmacokinetic Measurements of Maximum Plasma Concentration [Cmax], of N91115, lumacaftor, and ivacaftor [ Time Frame: baseline to 12 weeks ]
    Maximum Plasma Concentration [Cmax] measurements of N91115, lumacaftor and ivacaftor
  • Pharmacokinetic Measurements of Area Under the Curve (AUC) for N91115, Ivacaftor and lumacaftor [ Time Frame: baseline to 12 weeks ]
    AUC measurements of N91115, lumacaftor and ivacaftor
Same as current
Number of pulmonary exacerbations [ Time Frame: baseline to 12 weeks ]
Assessment of number of pulmonary exacerbations at baseline compared through 12 weeks
Same as current
 
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
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™).

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
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Cystic Fibrosis
  • Drug: Cavosonstat
    GSNOR inhibitor
    Other Name: N91115
  • Drug: Placebo
    Control sample with only capsule excipients and fillers
    Other Name: control
  • Placebo Comparator: Placebo
    Placebo Capsule
    Intervention: Drug: Placebo
  • Experimental: Cavosonstat (N91115) 200 mg
    Cavosonstat (N91115) 200 mg twice daily (BID)
    Intervention: Drug: Cavosonstat
  • Experimental: Cavosonstat (N91115) 400 mg
    Cavosonstat (N91115) 400 mg BID
    Intervention: Drug: Cavosonstat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
December 2016
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have been treated with lumacaftor/ivacaftor for at least 8 weeks prior to Day 1 (start of dosing)
  • A history of Sweat Chloride (SC) ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) (either before or after starting lumacaftor/ivacaftor treatment)
  • Body weight ≥ 40 kg
  • ppFEV1 40 - 85 % predicted (inclusive) at screening
  • Oxygen saturation ≥ 90% breathing ambient air at screening

Exclusion Criteria:

  • Any acute infection that requires treatment or hospitalization within 2 weeks of Study Day 1
  • Colonization with organisms associated with more rapid decline in pulmonary status, such as Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus
  • Any change in the regimen for chronic therapies for CF lung disease (e.g., Pulmozyme®, hypertonic saline, Azithromycin, TOBI®, Cayston®) within 4 weeks of Study Day 1
  • Are pregnant, planning a pregnancy, or breast-feeding at screening
  • Blood hemoglobin < 10 g/dL at screening
  • Serum albumin < 2.5 g/dL at screening
  • Abnormal liver function defined as ≥ 3 x upper limit of normal (ULN)
  • History of abnormal renal function within 3 months of screening
  • History of ventricular tachycardia or other clinically significant ventricular arrhythmias
  • History, including the screening assessment, of prolonged QT and/or QTcF (Fridericia's correction) interval
  • History of solid organ or hematological transplantation
  • History of alcohol abuse or drug abuse
  • Ongoing participation in another therapeutic clinical trial
  • Use of continuous (24 hr/day) or nocturnal supplemental oxygen
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02589236
N91115-2CF-05
Yes
Not Provided
Not Provided
Nivalis Therapeutics, Inc.
Nivalis Therapeutics, Inc.
Medidata Solutions
Principal Investigator: Scott Donaldson, MD University of North Carolina, Chapel Hill
Nivalis Therapeutics, Inc.
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP