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Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02846324
Recruitment Status : Completed
First Posted : July 27, 2016
Results First Posted : September 22, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Global Blood Therapeutics

Study Description
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Brief Summary:
This study is a randomized, double-blind, placebo-controlled trial in which eligible IPF subjects will be randomized to receive GBT440 or Placebo orally daily.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Hypoxemia Drug: GBT440 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Phase II Randomized, Placebo-Controlled Study of GBT440 to Evaluate the Safety, Tolerability, Pharmacokinetics and Effect on Hypoxemia in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Study Start Date : June 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GBT440 600 mg Dose
Parts A and B
 Drug: GBT440
Capsules which contain GBT440 drug substance in Swedish orange
Experimental: GBT440 900 mg Dose
Part A
 Drug: GBT440
Capsules which contain GBT440 drug substance in Swedish orange
Experimental: GBT440 1500 mg Dose
Part B
 Drug: GBT440
Capsules which contain GBT440 drug substance in Swedish orange
Placebo Comparator: Placebo
Parts A and B
 Drug: Placebo
Placebo capsules


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 [ Time Frame: Days 1 to 58 ]

Secondary Outcome Measures :
  1. Pharmacokinetic Profile of GBT440 Including Maximum Concentration [ Time Frame: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only ]
  2. Pharmacokinetic Profile of GBT440 Including Minimum Concentration [ Time Frame: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only ]
  3. Pharmacokinetic Profile of GBT440 Including Apparent Terminal Half Life [ Time Frame: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only ]
  4. Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest [ Time Frame: Baseline to Day 28 ]
    Data reported is change from baseline in Oxygen Saturation at rest

  5. Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry After Exercise [ Time Frame: Baseline to Day 28 ]
    Change from Baseline to Day 28 after 6MWT


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of IPF.
  • 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:

  • FEV1/FVC < 70%.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846324


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35233
United States, California
San Francisco, California, United States, 94143
United States, Colorado
Denver, Colorado, United States, 80206
United States, Florida
Miami, Florida, United States, 33136
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Louisiana
New Orleans, Louisiana, United States, 70122
United States, New York
New York, New York, United States, 10032
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19145
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Nashville, Tennessee, United States, 37212
United States, Utah
Salt Lake City, Utah, United States, 84108
United States, Virginia
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Global Blood Therapeutics
  Study Documents (Full-Text)

Documents provided by Global Blood Therapeutics:
Study Protocol  [PDF] December 21, 2016
Statistical Analysis Plan  [PDF] July 6, 2017

More Information
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Responsible Party: Global Blood Therapeutics
ClinicalTrials.gov Identifier: NCT02846324    
Other Study ID Numbers: GBT440-006
First Posted: July 27, 2016    Key Record Dates
Results First Posted: September 22, 2020
Last Update Posted: October 20, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Hypoxia
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory