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The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 JTZ-951 | Experimental | Tablets, 1 dose on Day 1 before hemodialysis |
|
| Dose 2 JTZ-951 | Experimental | Tablets, 1 dose on Day 8 after hemodialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JTZ-951 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis | Days 1 to 4 and 8 to 11 | |
| tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis | Days 1 to 4 and 8 to 11 | |
| AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis | Days 1 to 4 and 8 to 11 | |
| t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis | Days 1 to 4 and 8 to 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | 14 days | |
| Vital signs and ECG (electrocardiogram) | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hideyuki Yamamoto | Akros Pharma Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis | Minnesota | United States |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C000656654 | enarodustat |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |