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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02846324
First Posted: July 27, 2016
Last Update Posted: November 8, 2017
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.
Information provided by (Responsible Party):
Global Blood Therapeutics
  Purpose
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 Intervention Phase
Idiopathic Pulmonary Fibrosis Drug: GBT440 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Global Blood Therapeutics:

Primary Outcome Measures:
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: Days 1 to 28 ]

Secondary Outcome Measures:
  • Pharmacokinetic profile of GBT440 including maximum concentration [ Time Frame: Days 1 to 58 ]
  • Pharmacokinetic profile of GBT440 including minimum concentration [ Time Frame: Days 1 to 58 ]
  • Pharmacokinetic profile of GBT440 including apparent terminal half life [ Time Frame: Days 1 to 58 ]
  • Evaluate the effect of GBT440 on oxygen saturation using pulse oximetry at rest [ Time Frame: Screening to Day 58 ]
  • Evaluate the effect of GBT440 on oxygen saturation using pulse oximetry after exercise [ Time Frame: Screening to Day 58 ]

Enrollment: 39
Study Start Date: June 2016
Study Completion Date: November 2017
Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GBT440 Dose 1
Dose 1
Drug: GBT440
Capsules which contain GBT440 drug substance in Swedish orange
Experimental: GBT440 Dose 2
Dose 2
Drug: GBT440
Capsules which contain GBT440 drug substance in Swedish orange
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo capsules

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
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
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
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
  More Information

Responsible Party: Global Blood Therapeutics
ClinicalTrials.gov Identifier: NCT02846324     History of Changes
Other Study ID Numbers: GBT440-006
First Submitted: July 7, 2016
First Posted: July 27, 2016
Last Update Posted: November 8, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial