Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Pulmonary Fibrosis Hypoxemia | Drug: GBT440 Drug: Placebo | Phase 2 |
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 |

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 |
- 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 [ Time Frame: Baseline to Day 28 ]Data reported is change from baseline in Oxygen Saturation at rest
- 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

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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 |
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.

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
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 |
Documents provided by Global Blood Therapeutics:
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 |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Hypoxia |
Pathologic Processes Lung Diseases Respiratory Tract Diseases Signs and Symptoms, Respiratory |