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This study will provide information regarding the metabolic pathway of GBT440, the need for evaluation of potential drug-drug interactions, and the need for studies in special populations. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of GBT440, providing further quantitative information on the disposition of GBT440. The results from this study will permit a comprehensive comparison between animal and human routes of elimination and metabolic profiles of GBT440.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GBT440 | Experimental | GBT440 / [C14] GBT440 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GBT440 | Drug | GBT440 capsules followed by single dose of [C14] GBT440 oral suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the whole blood and plasma concentration versus time curve (AUC) | 0 to 648 hours post dose | |
| Peak whole blood and plasma concentration (Cmax) | 0 to 168 hours post dose | |
| Time to peak whole blood and plasma concentration (Tmax) | 0 to 168 hours post dose | |
| Half-life (T 1/2) | 0 to 168 hours post dose | |
| Percent total recovery of radioactivity in blood, urine, and feces | 0 to 648 hours post dose | |
| Identification of metabolites in whole blood, plasma, urine, and feces following [C14] GBT440 administration | 0 to 168 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Baseline to 27 days |
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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 |
|---|---|---|---|---|---|---|
| Covance Early Clinical Services | Madison | Wisconsin | 53704 | 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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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |