Study Assessing PTI-428 Safety, Tolerability, Pharmacokinetics and Effect in Subjects With Cystic Fibrosis
NCT ID: NCT03591094
Last Updated: 2020-02-27
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
40 participants
INTERVENTIONAL
2018-08-21
2019-02-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PTI-428 dose level 1
PTI-428
Active
PTI-428 dose level 2
PTI-428
Active
Placebo PTI-428
Placebo
Placebo
Interventions
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PTI-428
Active
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* On tezacaftor/ivacaftor dosing for both label indication and per label dosing for a minimum of 1 month on Day 1
* Forced expiratory volume in 1 second (FEV1) 40-90% predicted, inclusive
* Clinically stable with no significant changes in health status within 14 days of Day 1
* Non-smoker and non-tobacco user for a minimum of 28 days prior to screening and for the duration of the study
Exclusion Criteria
* History of cancer within the past 5 years (excluding cervical cancer in situ with curative therapy for at least one year prior to screening and non-melanoma skin cancer)
* History of organ transplantation
* Hospitalization, sinopulmonary infection, CF exacerbation, or other clinically significant infection or illness (as determined by the investigator) requiring an increase or addition of medication, such as antibiotics or corticosteroids, within 14 days of Day 1
* Initiation of any new chronic therapy (e.g., ibuprofen, hypertonic saline, azithromycin, Pulmozyme®, Cayston®, TOBI®)) or any change in chronic therapy (excluding pancreatic enzyme replacement therapy) within 28 days prior to Day 1
* History or current evidence of alcohol or drug abuse or dependence within 12 months of screening as determined by the investigator
* Pregnant or nursing women
18 Years
ALL
No
Sponsors
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Proteostasis Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
Stanford University
Stanford, California, United States
National Jewish Health
Denver, Colorado, United States
Central Florida Pulmonary Group
Altamonte Springs, Florida, United States
Northwestern University
Chicago, Illinois, United States
Cystic Fibrosis Center, Children's Hospital of Illinois at OSF Saint Francis Medical Center
Peoria, Illinois, United States
University of Iowa, Roy J and Lucille A Carver College of Medicine
Iowa City, Iowa, United States
Universitey of Louisville, Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Michigan Medicine, University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Dartmouth Hitchcock Medical Center
Manchester, New Hampshire, United States
Mount Sinai Beth Israel
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
New York Medical College
Valhalla, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The University of Texas Health Science Center at Tyler - Center for Clinical Research
Tyler, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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PTI-428-06
Identifier Type: -
Identifier Source: org_study_id
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