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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Global Blood Therapeutics
Sponsor:
Information provided by (Responsible Party):
Global Blood Therapeutics
ClinicalTrials.gov Identifier:
NCT02846324
First received: July 7, 2016
Last updated: April 6, 2017
Last verified: April 2017
  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 ]

Estimated Enrollment: 30
Study Start Date: June 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: April 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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02846324

Contacts
Contact: Nicholas Vlahakis, M.D. 650-741-7730 nvlahakis@globalbloodtx.com

Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States, 35233
Contact: Sharonda Keazor    205-975-8335    skeazor@uabmc.edu   
United States, California
Not yet recruiting
San Francisco, California, United States, 94143
Contact: Darren Leong    415-353-2296    darren.leong@ucsf.edu   
United States, Colorado
Recruiting
Denver, Colorado, United States, 80206
Contact: Laurie Burnside    303-398-1554    burnsidel@njhealth.org   
United States, Florida
Recruiting
Miami, Florida, United States, 33136
Contact: Emmanuelle Simonet    305-243-6372    esimonet@med.miami.edu   
United States, Kansas
Recruiting
Kansas City, Kansas, United States, 66160
Contact: Marla Watson    913-588-4022    mwatson5@kumc.edu   
United States, Louisiana
Recruiting
New Orleans, Louisiana, United States, 70122
Contact: Christine Glynn    504-988-0743    cglynn1@tulane.edu   
United States, New York
Recruiting
New York, New York, United States, 10032
Contact: Amika McBurnie    212-342-1518    akm2192@cumc.columbia.edu   
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19145
Contact: Sylvia Johnson    215-707-4679    sylvia.johnson@tuhs.temple.edu   
United States, South Carolina
Recruiting
Charleston, South Carolina, United States, 29425
Contact: Ashley Warden    843-792-2081    jonesash@musc.edu   
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37212
Contact: Jim DelGreco    615-343-7068    james.del.greco@vanderbilt.edu   
United States, Utah
Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Lisa Weaver    801-587-7855    lisa.weaver@hsc.utah.edu   
United States, Virginia
Recruiting
Falls Church, Virginia, United States, 22042
Contact: Edwinia Battle    703-776-3067    edwinia.battle@inova.org   
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
Study First Received: July 7, 2016
Last Updated: April 6, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017