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Sponsor discontinued IPF Program on 23-Oct. 2017 based on POC studies
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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
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To evaluate the effect of GBT440 on oxygen saturation at rest and exercise, under hypoxic conditions, at Day 15 compared to Baseline.
This study in healthy subjects will evaluate GBT440 and its effects on cardio-pulmonary function under both normoxic and hypoxic conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GBT440 Dose 1 | Experimental | Dose 1 |
|
| GBT440 Dose 2 | Experimental | Dose 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GBT440 | Drug | Capsules which contain GBT440 drug substance in Swedish Orange |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in oxygen saturation (%) at rest and exercise, under hypoxic conditions | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal oxygen uptake VO2 max (mL/kg/min) under normoxic and hypoxic conditions | Day 15 | |
| Cardiac output (L/min) under normoxic and hypoxic conditions | Day 15 | |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Ganesh Balaratnam, MBChB, BAO | Global Blood Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| C000628792 | voxelotor |
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| Oxy-hemoglobin dissociation curve p50, under hypoxic conditions |
| Day 15 |
| Perceived dyspnea score (1-10), under normoxic and hypoxic conditions | Day 15 |
| Frequency and severity of treatment-emergent adverse events (TEAEs) as assessed by (NCI CTCAE Version 4.03) | Day 15 |