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The purpose of this study to evaluate the effect of concomitant administration of GBT440 on caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a CYP2C19 probe substrate), and midazolam (a CYP3A4 probe substrate) plasma concentrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed sequence, 2-periods | Experimental | An open-label, fixed sequence, 2-period drug interaction study Period 1 Treatment A: Single dose of drug cocktail on Day 1 Period 2 Treatment B: GBT440 on Days 1 through 3 and Treatment C: Single dose of drug cocktail on Day 4 and GBT440 on Days 4 through 7 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GBT440 | Drug | GBT440 capsules followed by Caffeine, S-warfarin+vitamin K, Omeprazole, and Midazolam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration(Cmax) for caffeine, S warfarin, omeprazole, and midazolam in plasma | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 | |
| Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUCt) for caffeine, S warfarin, omeprazole, and midazolam | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 | |
| Area under the plasma concentration time curve from time 0 extrapolated to infinity (AUCinf) for caffeine, S warfarin, omeprazole, and midazolam | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| The time that Cmax was observed (tmax) for caffeine, S warfarin, omeprazole, and midazolam in plasma | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 | |
| Terminal elimination half-life (t½) for caffeine, S warfarin, omeprazole, and midazolam in plasma |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) and serious adverse events | Baseline to Period 2 Day 25 | |
| Change in clinical laboratory tests | Baseline to Period 2 Day 25 | |
| Change in physical examination findings |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carla Washington, PhD | Global Blood Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Phase Services, LLC Clinical Research Unit | San Antonio | Texas | 78209 | United States |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C000628792 | voxelotor |
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| 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 |
| Cmax for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 |
| tmax, for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 |
| AUCt for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 |
| AUCinf for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 |
| t1/2 for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 |
| Ratio of metabolite to parent Cmax corrected for molecular weight (Cmax M/P) for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 |
| Ratio of metabolite to parent AUCt corrected for molecular weight (AUCt M/P)for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 |
| Ratio of metabolite to parent AUCinf corrected for molecular weight (AUCinf M/P) for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 |
| Cmax for GBT440 in whole blood and plasma | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 |
| tmax for GBT440 in whole blood and plasma | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 |
| AUC from time 0 to 24 hours (AUC0-24) (Days 4 and 7) for GBT440 in whole blood and plasma | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 |
| t1/2 (Day7) for GBT440 in whole blood and plasma | 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 |
| Baseline to Period 2 Day 25 |
| Change in vital signs | Baseline to Period 2 Day 25 |
| Change in pulse oximetry findings | Baseline to Period 2 Day 25 |
| Change in electrocardiograms (ECGs) | Baseline to Period 2 Day 25 |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |