Back to resultsA Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
Primary Purpose
Hyperkalemia
Status
Completed
Phase
Phase 1
Locations
Hong Kong
Study Type
Interventional
Intervention
Sodium Zirconium Cyclosilicate (ZS)
Sponsored by
About this trial
This is an interventional treatment trial for Hyperkalemia focused on measuring Healthy Chinese Subjects, Pharmacodynamic Study
Eligibility Criteria
Key Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- Female and/or male healthy Chinese subjects aged between 18 and 55 inclusive who reside in Hong Kong
- Ability to have repeated blood draws or effective venous catheterization
- 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:
- Participation in another clinical study with an investigational product during the last 3 months
- 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.
- 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
- 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.
- Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ZS 5g, qd
ZS 10g, qd
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03283267
Brief Title
A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
Official Title
A Single-center Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
November 23, 2017 (Actual)
Study Completion Date
November 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkalemia
Keywords
Healthy Chinese Subjects, Pharmacodynamic Study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ZS 5g, qd
Arm Type
Experimental
Arm Description
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.
Arm Title
ZS 10g, qd
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sodium Zirconium Cyclosilicate (ZS)
Intervention Description
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 Measure Information:
Title
Mean change from baseline to ZS treatment period in urine potassium excretion.
Description
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.
Secondary Outcome Measure Information:
Title
Mean change from baseline to ZS treatment period in urine sodium excretion.
Description
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.
Title
Mean change from baseline to ZS treatment period in serum potassium (S-K).
Description
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.
Other Pre-specified Outcome Measures:
Title
Number of subjects with adverse events
Time Frame
From Day 1 through Follow-up visit
Title
Changes in vital signs
Time Frame
Through study completion, up to 10 days
Title
Changes in standard Electrocardiograph (ECG ) parameters
Time Frame
Through study completion, up to 10 days
Title
Changes in standard physical examination parameters including height
Time Frame
Through study completion, up to 10 days
Title
Changes in standard clinical chemistry lab parameters
Time Frame
Through study completion, up to 10 days
Title
Changes in standard hematology lab parameters
Time Frame
Through study completion, up to 10 days
Title
Changes in Serum calcium (S-Ca)
Time Frame
Through study completion, up to 10 days
Title
Changes in Serum magnesium (S-Mg)
Time Frame
Through study completion, up to 10 days
Title
Changes in Serum sodium (S-Na)
Time Frame
Through study completion, up to 10 days
Title
Changes in Serum phosphate (S-PO4)
Time Frame
Through study completion, up to 10 days
Title
Changes in Serum bicarbonate (S-HCO3)
Time Frame
Through study completion, up to 10 days
Title
Changes in Blood urea nitrogen (BUN)
Time Frame
Through study completion, up to 10 days
Title
Number of subjects with Serious adverse events
Time Frame
Through study completion and follow-up visit, up to 34 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
Provision of informed consent prior to any study specific procedures
Female and/or male healthy Chinese subjects aged between 18 and 55 inclusive who reside in Hong Kong
Ability to have repeated blood draws or effective venous catheterization
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:
Participation in another clinical study with an investigational product during the last 3 months
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.
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
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.
Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening.
Facility Information:
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
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A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
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