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Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest (Zephyr)

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: NCT02989168
Recruitment Status : Terminated (The study was terminated due to lack of clinically meaningful benefit)
First Posted : December 12, 2016
Results First Posted : August 21, 2020
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Global Blood Therapeutics

Study Description
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Brief Summary:
This is an open label study in which eligible IPF subjects who are using supplemental oxygen at rest will receive GBT440 orally daily.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase II Open Label Study to Evaluate the Effect of GBT440 on Hypoxemia in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Who Are Using Supplemental Oxygen at Rest (ZEPHYR)
Study Start Date : November 2016
Actual Primary Completion Date : October 23, 2017
Actual Study Completion Date : October 23, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GBT440 900 mg Dose

Part A, 900 mg

GBT440: Capsules which contain GBT440 drug substance in Swedish orange

 Drug: GBT440
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
Experimental: GBT440 1500 mg Dose

Part B , 1500 mg

GBT440: Capsules which contain GBT440 drug substance in Swedish orange

 Drug: GBT440
GBT440: Capsules which contain GBT440 drug substance in Swedish orange


Outcome Measures
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Primary Outcome Measures :
  1. Change in Oxygen Saturation at End of Treatment Period Compared to Baseline [ Time Frame: Days 1 to 90 ]

Secondary Outcome Measures :
  1. Change in Supplemental Oxygen Requirement at End of Treatment Period Compared to Baseline [ Time Frame: Days 1 to 90 ]
  2. Evaluate the Effect of GBT440 on Resting and Post-exercise Alveolar-arterial O2 Tension Difference [P(A-a) O2] at End of Treatment Period Compared to Baseline [ Time Frame: Days 1 to 90 ]
  3. Evaluate the Effect of GBT440 on Performance of the 6MWT [ Time Frame: Days 1 to 90 ]
  4. Evaluate the Effect of GBT440 on IPF Related Symptoms Using Patient Related Outcomes [ Time Frame: Days 1 to 90 ]
  5. Evaluate Pulmonary Function Using Pulmonary Function Tests (FVC and DLco) [ Time Frame: Days 1 to 90 ]
    Spirometry measurements will include forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLco).

  6. Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Days 1 to 90 ]
  7. Pharmacokinetic Parameters of GBT440 in Plasma and Whole Blood (Minimum Concentration (Cmin)) [ Time Frame: Day 1 (15 mins post-dose and 2-4h post-dose), Day 15 (pre-dose), Day 30 (pre-dose), Day 60 (pre-dose and 2-4h post-dose), Day 90 (pre-dose), Day 105 (during study visit), and Day 120 (during study visit) ]
    PK parameters of GBT440 administered daily orally for 90 days in plasma and whole blood, including but not limited to, minimum concentration (Cmin), at steady state.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of IPF.
  • Receiving supplemental oxygen for use at rest.
  • Weight ≥ 40 kg.
  • Male or female of child bearing potential willing and able to use highly effective methods of contraception from study start to 30 days after the last dose of study drug.

Exclusion Criteria:

  • FEV1/FVC < 70%
  • History of other interstitial lung diseases.
  • Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of screening.
  • Corticosteroid (> 10 mg per day of prednisone or an equivalent) administered for 7 days or longer, within 30 days of screening.
  • 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).
  • Female who is breast-feeding or pregnant
  • Current smoker or history of smoking within 3 months from screening
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): NCT02989168


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35233
United States, Colorado
Denver, Colorado, United States, 80206
United States, Louisiana
New Orleans, Louisiana, United States, 70122
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19140
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Utah
Salt Lake City, Utah, United States, 84108
United Kingdom
London, United Kingdom, SW3 6NP
Manchester, United Kingdom, M23 9QZ
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Global Blood Therapeutics
  Study Documents (Full-Text)

Documents provided by Global Blood Therapeutics:
Study Protocol  [PDF] June 5, 2017
Statistical Analysis Plan  [PDF] November 15, 2017

More Information
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Responsible Party: Global Blood Therapeutics
ClinicalTrials.gov Identifier: NCT02989168    
Other Study ID Numbers: GBT440-026
First Posted: December 12, 2016    Key Record Dates
Results First Posted: August 21, 2020
Last Update Posted: August 21, 2020
Last Verified: July 2020
Keywords provided by Global Blood Therapeutics:
Idiopathic pulmonary fibrosis
hypoxemia
oxygen
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