Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF
NCT ID: NCT02846324
Last Updated: 2020-10-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
2016-06-30
2017-11-30
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
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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GBT440 600 mg Dose
Parts A and B
GBT440
Capsules which contain GBT440 drug substance in Swedish orange
GBT440 900 mg Dose
Part A
GBT440
Capsules which contain GBT440 drug substance in Swedish orange
GBT440 1500 mg Dose
Part B
GBT440
Capsules which contain GBT440 drug substance in Swedish orange
Placebo
Parts A and B
Placebo
Placebo capsules
Interventions
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GBT440
Capsules which contain GBT440 drug substance in Swedish orange
Placebo
Placebo capsules
Eligibility Criteria
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Inclusion Criteria
* Oxygen desaturation with exercise.
* Completion of the baseline 6MWT
* Weight ≥ 50 kg
* Male or female of child bearing potential willing and able to use highly effective methods of contraception from study start to 3 months after the last dose of study drug.
Exclusion Criteria
* Subjects on supplemental oxygen therapy at rest.
* History of other interstitial lung diseases.
* Significant polycythemia.
* Female who is breast-feeding or pregnant.
* Known current malignancy or history of malignancy within the last 2 years prior to screening.
* Use of cytotoxic and/or immunosuppressant medications within 30 days screening.
* Hospitalization due to an exacerbation of IPF within 30 days of screening
* Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of screening
* Corticosteroids (\> 10 mg per day of prednisone or an equivalent) within 30 days of screening.
* Current smoker or history of smoking within 3 months of screening.
* Currently or, in the opinion of the investigator, soon to be listed for lung transplant.
* History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within 6 months of screening.
* Any condition possibly affecting drug absorption.
* Participated in another clinical trial of an investigational drug (or medical device) within 30 days or 5-half-lives, whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device).
* Subject who, for any reason, is deemed by the investigator to be inappropriate for this study.
45 Years
80 Years
ALL
No
Sponsors
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Global Blood Therapeutics
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
San Francisco, California, United States
Denver, Colorado, United States
Miami, Florida, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Salt Lake City, Utah, United States
Falls Church, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GBT440-006
Identifier Type: -
Identifier Source: org_study_id
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