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A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)

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ClinicalTrials.gov Identifier: NCT03283267
Recruitment Status : Completed
First Posted : September 14, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hyperkalemia Drug: Sodium Zirconium Cyclosilicate (ZS) Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
Actual Study Start Date : October 24, 2017
Actual Primary Completion Date : November 23, 2017
Actual Study Completion Date : November 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium
Drug Information available for: Zirconium

Arm Intervention/treatment
Experimental: ZS 5g, qd
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)
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.

Experimental: ZS 10g, qd
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.




Primary Outcome Measures :
  1. Mean change from baseline to ZS treatment period in urine potassium excretion. [ Time Frame: Study Day 3 and 4 vs Study Day 7 and 8. ]
    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).


Secondary Outcome Measures :
  1. Mean change from baseline to ZS treatment period in urine sodium excretion. [ Time Frame: Study Day 3 and 4 vs Study Day 7 and 8. ]
    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).

  2. Mean change from baseline to ZS treatment period in serum potassium (S-K). [ Time Frame: Study Day 3 and 4 vs Study Day 7 and 8. ]
    Mean change in S-K from the Baseline Period (Day 3 and 4) to the ZS Treatment Period (Day 7 and 8).


Other Outcome Measures:
  1. Number of subjects with adverse events [ Time Frame: From Day 1 through Follow-up visit ]
  2. Changes in vital signs [ Time Frame: Through study completion, up to 10 days ]
  3. Changes in standard Electrocardiograph (ECG ) parameters [ Time Frame: Through study completion, up to 10 days ]
  4. Changes in standard physical examination parameters including height [ Time Frame: Through study completion, up to 10 days ]
  5. Changes in standard clinical chemistry lab parameters [ Time Frame: Through study completion, up to 10 days ]
  6. Changes in standard hematology lab parameters [ Time Frame: Through study completion, up to 10 days ]
  7. Changes in Serum calcium (S-Ca) [ Time Frame: Through study completion, up to 10 days ]
  8. Changes in Serum magnesium (S-Mg) [ Time Frame: Through study completion, up to 10 days ]
  9. Changes in Serum sodium (S-Na) [ Time Frame: Through study completion, up to 10 days ]
  10. Changes in Serum phosphate (S-PO4) [ Time Frame: Through study completion, up to 10 days ]
  11. Changes in Serum bicarbonate (S-HCO3) [ Time Frame: Through study completion, up to 10 days ]
  12. Changes in Blood urea nitrogen (BUN) [ Time Frame: Through study completion, up to 10 days ]
  13. Number of subjects with Serious adverse events [ Time Frame: Through study completion and follow-up visit, up to 34 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Female and/or male healthy Chinese subjects aged between 18 and 55 inclusive who reside in Hong Kong
  3. Ability to have repeated blood draws or effective venous catheterization
  4. Willing to consume food and beverages using a standardized daily diet containing 40 (± 10%) mEq/day sodium and 128 (± 10%) mEq/day potassium provided by the research site

Key Exclusion Criteria:

  1. Participation in another clinical study with an investigational product during the last 3 months
  2. Subjects who were receiving concomitant medications including vitamins, dietary supplements and herbal preparations within 2 weeks prior to Study Day 1 of the Diet Run-in Period.
  3. Current and/or past history of alcohol abuse within the past year or a positive results (exceed normal range) of breath test for alcohol abuse
  4. Current and/or past history of drugs abuse within the past year or a positive drug abuse screen, e. g. methylenedioxymethamphetamine, opiate, barbiturates, benzodiazepines, ketamine, cocaine, amphetamine, methamphetamine, marijuana, and methadone.
  5. Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283267


Locations
Hong Kong
Research Site
Hong Kong, Hong Kong
Sponsors and Collaborators
AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03283267     History of Changes
Other Study ID Numbers: D9483C00001
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AstraZeneca:
Healthy Chinese Subjects, Pharmacodynamic Study

Additional relevant MeSH terms:
Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases