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This is a single center, inpatient, open label pharmacodynamic study to determine the effect of 5 g and 10 g doses of Sodium Zirconium Cyclosilicate (ZS) administered once daily (qd) for 4 days on potassium and sodium excretion in healthy Chinese subjects on a standardized, low sodium and high potassium diet.
This study will be conducted at 1 study centre in Hong Kong. Approximately 22 Subjects will be screened to achieve 20 subjects completing the study. Subjects will be randomized to receive ZS 5 g or 10 g (1:1) once daily (qd) in conjunction with breakfast and will be continued with a standard diet during the ZS treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZS 5g, qd | Experimental | Subjects randomized to this arm will receive ZS 5 g qd in conjunction with breakfast during the ZS treatment period and will be continued with a standard diet. |
|
| ZS 10g, qd | Experimental | Subjects randomized to this arm will receive ZS 10 g qd in conjunction with breakfast during the ZS treatment period and will be continued with a standard diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Zirconium Cyclosilicate (ZS) | Drug | Sodium zirconium cyclosilicate (ZS) is a non-absorbed, inorganic crystalline compound that selectively captures potassium ions in exchange for sodium and hydrogen ions in the gastrointestinal tract after oral administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline to ZS treatment period in urine potassium excretion. | The 48- hour urine potassium excretion on Study Days 3 and 4 (baseline) will be compared with 48-hour urine potassium excretion on Study Days 7 and 8 (on study drug). | Study Day 3 and 4 vs Study Day 7 and 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline to ZS treatment period in urine sodium excretion. | The 48- hour urine sodium excretion on Study Days 3 and 4 (baseline) will be compared with 48- hour urine sodium excretion on Study Days 7 and 8 (on study drug). | Study Day 3 and 4 vs Study Day 7 and 8. |
| Mean change from baseline to ZS treatment period in serum potassium (S-K). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | From Day 1 through Follow-up visit | |
| Changes in vital signs | Through study completion, up to 10 days | |
| Changes in standard Electrocardiograph (ECG ) parameters |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000597310 | sodium zirconium cyclosilicate |
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Mean change in S-K from the Baseline Period (Day 3 and 4) to the ZS Treatment Period (Day 7 and 8). |
| Study Day 3 and 4 vs Study Day 7 and 8. |
| Through study completion, up to 10 days |
| Changes in standard physical examination parameters including height | Through study completion, up to 10 days |
| Changes in standard clinical chemistry lab parameters | Through study completion, up to 10 days |
| Changes in standard hematology lab parameters | Through study completion, up to 10 days |
| Changes in Serum calcium (S-Ca) | Through study completion, up to 10 days |
| Changes in Serum magnesium (S-Mg) | Through study completion, up to 10 days |
| Changes in Serum sodium (S-Na) | Through study completion, up to 10 days |
| Changes in Serum phosphate (S-PO4) | Through study completion, up to 10 days |
| Changes in Serum bicarbonate (S-HCO3) | Through study completion, up to 10 days |
| Changes in Blood urea nitrogen (BUN) | Through study completion, up to 10 days |
| Number of subjects with Serious adverse events | Through study completion and follow-up visit, up to 34 Days |