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A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment disease and healthy subjects with normal renal function.
Up to 40 adult subjects will be enrolled. Safety and PK assessments will be performed at selected time points throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GBT440 Dose 1: Severe Renal Impairment | Experimental | eGFR < 30 mL/min/1.73m2, not on dialysis |
|
| GBT440 Dose 1: Moderate Renal Impairment | Experimental | 30 mL/min/1.73m2 = or < eGFR < 60 mL/min/1.73m2 |
|
| GBT440 Dose 1: Mild Renal Impairment | Experimental | 60 mL/min/1.73m2 = or < eGFR < 90 mL/min/1.73m2 |
|
| GBT440 Dose 1: Normal Renal function | Experimental | eGFR > or = 90 mL/min/1.73m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GBT440 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function | Maximum observed plasma concentration | 28 days max |
| Tmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function | 28 days max | |
| AUC of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function | 28 days max | |
| T1/2 of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function | 28 days max |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with treatment-related Adverse events | 28 days max |
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Inclusion Criteria:
All subjects:
Subjects with renal impairment:
Healthy subjects:
Exclusion Criteria:
All subjects:
Subjects with renal impairment:
- History of clinically significant hepatic disease e.g. hepatitis, cirrhosis and or liver enzymes (ALT, AST, GGT and total bilirubin) > 5 times the upper limit of normal within the past year
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| Name | Affiliation | Role |
|---|---|---|
| Carla Washington | Global Blood Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| OCRC |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000628792 | voxelotor |
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Multiple-center, nonrandomized, open-label, parallel group study
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| Orlando |
| Florida |
| 32809 |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |