Trial · NCT02846324
Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF
NCT02846324, Phase 2, Completed, Global Blood Therapeutics; results first posted 2020-09-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF. Trials, record NCT02846324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02846324
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF
- NCT number
- NCT02846324
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- Global Blood Therapeutics
- Conditions
- Idiopathic Pulmonary Fibrosis, Hypoxemia
- Interventions
- GBT440, Placebo
- First posted
- 2016-07-27
- Last updated
- 2020-10-20
- Results first posted
- 2020-09-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 | Days 1 to 58 | |
| Secondary | Pharmacokinetic Profile of GBT440 Including Maximum Concentration | 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 | |
| Secondary | Pharmacokinetic Profile of GBT440 Including Minimum Concentration | 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 | |
| Secondary | Pharmacokinetic Profile of GBT440 Including Apparent Terminal Half Life | 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 | |
| Secondary | Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest | Baseline to Day 28 | Data reported is change from baseline in Oxygen Saturation at rest |
| Secondary | Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry After Exercise | Baseline to Day 28 | Change from Baseline to Day 28 after 6MWT |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 | Days 1 to 58 | Participant had at least one dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetic Profile of GBT440 Including Maximum Concentration | 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 | Complete PK data was not analyzable for any participant. | ||
| SECONDARY | Pharmacokinetic Profile of GBT440 Including Minimum Concentration | 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 | Per protocol, analysis was to be conducted on complete PK analysis population; insufficient number of samples collected for pre-specified analysis. | ||
| SECONDARY | Pharmacokinetic Profile of GBT440 Including Apparent Terminal Half Life | 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 | Complete PK data were not analyzable for any participant. | ||
| SECONDARY | Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest | Baseline to Day 28 | percent oxygen (%) | LEAST_SQUARES_MEAN | |
| SECONDARY | Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry After Exercise | Baseline to Day 28 | 6MWT | percent oxygen (%) | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 | Placebo | 8 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 | GBT440 600 mg Dose | 7 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 | GBT440 900mg Dose | 4 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 | GBT440 1500mg Dose | 11 | Participants | ||
| Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest | Placebo | -1.1 | Standard Error 0.59 | percent oxygen (%) | |
| Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest | GBT440 Dose 1 | 0.3 | Standard Error 0.77 | percent oxygen (%) | |
| Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest | GBT440 Dose 2 | 0.4 | Standard Error 0.76 | percent oxygen (%) | |
| Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest | GBT440 Dose 3 | 0.9 | Standard Error 0.57 | percent oxygen (%) | |
| Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry After Exercise | Placebo | -1.7 | Standard Error 1.64 | percent oxygen (%) | |
| Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry After Exercise | GBT440 Dose 1 | 2.9 | Standard Error 2.11 | percent oxygen (%) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GBT440 600 mg Dose | 9 | |
| Overall Study | STARTED | GBT440 900 mg Dose | 6 | |
| Overall Study | STARTED | GBT440 1500 mg Dose | 14 | |
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | Completed Study Treatment | GBT440 600 mg Dose | 7 | |
| Overall Study | Completed Study Treatment | GBT440 900 mg Dose | 5 | |
| Overall Study | Completed Study Treatment | GBT440 1500 mg Dose | 11 | |
| Overall Study | Completed Study Treatment | Placebo | 10 | |
| Overall Study | COMPLETED | GBT440 600 mg Dose | 7 | |
| Overall Study | COMPLETED | GBT440 900 mg Dose | 6 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events276
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | bradycardia | Cardiac disorders | Placebo | 0 | 10 | |
| other | bradycardia | Cardiac disorders | GBT440 600 mg Dose | 0 | 9 | |
| other | bradycardia | Cardiac disorders | GBT440 900 mg Dose | 1 | 6 | |
| other | bradycardia | Cardiac disorders | GBT440 1500 mg Dose | 0 | 14 | |
| other | sinus bradycardia | Cardiac disorders | Placebo | 0 | 10 | |
| other | sinus bradycardia | Cardiac disorders | GBT440 600 mg Dose | 0 | 9 | |
| other | sinus bradycardia | Cardiac disorders | GBT440 900 mg Dose | 1 | 6 | |
| other | sinus bradycardia | Cardiac disorders | GBT440 1500 mg Dose | 0 | 14 | |
| other | ventricular extrasystoles | Cardiac disorders | Placebo | 0 | 10 | |
| other | ventricular extrasystoles | Cardiac disorders | GBT440 600 mg Dose | 0 | 9 |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 10 |
| Total, all-cause mortality | GBT440 600 mg Dose | 0 | 9 |
| Total, all-cause mortality | GBT440 900 mg Dose | 0 | 6 |
| Total, all-cause mortality | GBT440 1500 mg Dose | 0 | 14 |
| Total, other adverse events | Placebo | 8 | 10 |
| Total, other adverse events | GBT440 600 mg Dose | 7 | 9 |
| Total, other adverse events | GBT440 900 mg Dose | 4 | 6 |
| Total, other adverse events | GBT440 1500 mg Dose | 11 | 14 |
| Total, serious adverse events | Placebo | 0 | 10 |
| Total, serious adverse events | GBT440 600 mg Dose | 2 | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02846324
GET https://conductscience.org/api/trials/v1/NCT02846324/events?page=2