Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation
NCT ID: NCT02589236
Last Updated: 2017-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
138 participants
INTERVENTIONAL
2015-11-30
2016-12-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo Capsule
Placebo
Control sample with only capsule excipients and fillers
Cavosonstat (N91115) 200 mg
Cavosonstat (N91115) 200 mg twice daily (BID)
Cavosonstat
GSNOR inhibitor
Cavosonstat (N91115) 400 mg
Cavosonstat (N91115) 400 mg BID
Cavosonstat
GSNOR inhibitor
Interventions
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Cavosonstat
GSNOR inhibitor
Placebo
Control sample with only capsule excipients and fillers
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medidata Solutions
INDUSTRY
Nivalis Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Donaldson, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of Alabama
Birmingham, Alabama, United States
Banner University of Arizona Medical Center
Tucson, Arizona, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
UC Davis Medical Center
Sacramento, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
Tampa General Hospital
Tampa, Florida, United States
St. Luke's CF Center of Idaho
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Saint Francis Medical Center
Peoria, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa Children's Hospital
Iowa City, Iowa, United States
Via Christi Research
Wichita, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Wayne State University-Harper
Detroit, Michigan, United States
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
St. Louis University
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Morristown Medical Center
Morristown, New Jersey, United States
Columbia University
New York, New York, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital - Case Medical Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
ProMedica Toledo Children's Hospital
Toledo, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Dell Children's Hospital | Austin Children's Chest Associates
Austin, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Medical Center of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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N91115-2CF-05
Identifier Type: -
Identifier Source: org_study_id
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