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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
39
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
Time frame: Days 1 to 58
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
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
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
Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest
Data reported is change from baseline in Oxygen Saturation at rest
Time frame: Baseline to Day 28
Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry After Exercise
Change from Baseline to Day 28 after 6MWT
Time frame: Baseline to Day 28
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Miami, Florida, United States
Unnamed facility
Kansas City, Kansas, United States
Unnamed facility
New Orleans, Louisiana, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Unnamed facility
Charleston, South Carolina, United States
Unnamed facility
Nashville, Tennessee, United States
...and 2 more locations