A Phase 1 interventional study of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia, sponsored by AstraZeneca. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-19.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
Drug: Sodium Zirconium Cyclosilicate (ZS)
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.
Drug: Sodium Zirconium Cyclosilicate (ZS)
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.
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).
Time frame: Study Day 3 and 4 vs Study Day 7 and 8.
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).
Time frame: Study Day 3 and 4 vs Study Day 7 and 8.
Mean change from baseline to ZS treatment period in serum potassium (S-K).
Mean change in S-K from the Baseline Period (Day 3 and 4) to the ZS Treatment Period (Day 7 and 8).
Time frame: Study Day 3 and 4 vs Study Day 7 and 8.
Number of subjects with adverse events
Time frame: From Day 1 through Follow-up visit
Changes in vital signs
Time frame: Through study completion, up to 10 days
Changes in standard Electrocardiograph (ECG ) parameters
Time frame: Through study completion, up to 10 days
Changes in standard physical examination parameters including height
Time frame: Through study completion, up to 10 days
Changes in standard clinical chemistry lab parameters
Time frame: Through study completion, up to 10 days
Changes in standard hematology lab parameters
Time frame: Through study completion, up to 10 days
Changes in Serum calcium (S-Ca)
Time frame: Through study completion, up to 10 days
Changes in Serum magnesium (S-Mg)
Time frame: Through study completion, up to 10 days
Changes in Serum sodium (S-Na)
Time frame: Through study completion, up to 10 days
Changes in Serum phosphate (S-PO4)
Time frame: Through study completion, up to 10 days
Changes in Serum bicarbonate (S-HCO3)
Time frame: Through study completion, up to 10 days
Changes in Blood urea nitrogen (BUN)
Time frame: Through study completion, up to 10 days
Number of subjects with Serious adverse events
Time frame: Through study completion and follow-up visit, up to 34 Days
Plan to share: No
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