<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03283267</url>
  </required_header>
  <id_info>
    <org_study_id>D9483C00001</org_study_id>
    <nct_id>NCT03283267</nct_id>
  </id_info>
  <brief_title>A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)</brief_title>
  <official_title>A Single-center Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single center, inpatient, open label pharmacodynamic study to determine the effect&#xD;
      of 5 g and 10 g doses of Sodium Zirconium Cyclosilicate (ZS) administered once daily (qd) for&#xD;
      4 days on potassium and sodium excretion in healthy Chinese subjects on a standardized, low&#xD;
      sodium and high potassium diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be conducted at 1 study centre in Hong Kong. Approximately 22 Subjects will&#xD;
      be screened to achieve 20 subjects completing the study. Subjects will be randomized to&#xD;
      receive ZS 5 g or 10 g (1:1) once daily (qd) in conjunction with breakfast and will be&#xD;
      continued with a standard diet during the ZS treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2017</start_date>
  <completion_date type="Actual">November 23, 2017</completion_date>
  <primary_completion_date type="Actual">November 23, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change from baseline to ZS treatment period in urine potassium excretion.</measure>
    <time_frame>Study Day 3 and 4 vs Study Day 7 and 8.</time_frame>
    <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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline to ZS treatment period in urine sodium excretion.</measure>
    <time_frame>Study Day 3 and 4 vs Study Day 7 and 8.</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline to ZS treatment period in serum potassium (S-K).</measure>
    <time_frame>Study Day 3 and 4 vs Study Day 7 and 8.</time_frame>
    <description>Mean change in S-K from the Baseline Period (Day 3 and 4) to the ZS Treatment Period (Day 7 and 8).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>From Day 1 through Follow-up visit</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in vital signs</measure>
    <time_frame>Through study completion, up to 10 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in standard Electrocardiograph (ECG ) parameters</measure>
    <time_frame>Through study completion, up to 10 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in standard physical examination parameters including height</measure>
    <time_frame>Through study completion, up to 10 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in standard clinical chemistry lab parameters</measure>
    <time_frame>Through study completion, up to 10 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in standard hematology lab parameters</measure>
    <time_frame>Through study completion, up to 10 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Serum calcium (S-Ca)</measure>
    <time_frame>Through study completion, up to 10 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Serum magnesium (S-Mg)</measure>
    <time_frame>Through study completion, up to 10 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Serum sodium (S-Na)</measure>
    <time_frame>Through study completion, up to 10 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Serum phosphate (S-PO4)</measure>
    <time_frame>Through study completion, up to 10 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Serum bicarbonate (S-HCO3)</measure>
    <time_frame>Through study completion, up to 10 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Blood urea nitrogen (BUN)</measure>
    <time_frame>Through study completion, up to 10 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of subjects with Serious adverse events</measure>
    <time_frame>Through study completion and follow-up visit, up to 34 Days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Hyperkalemia</condition>
  <arm_group>
    <arm_group_label>ZS 5g, qd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ZS 10g, qd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Zirconium Cyclosilicate (ZS)</intervention_name>
    <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.</description>
    <arm_group_label>ZS 10g, qd</arm_group_label>
    <arm_group_label>ZS 5g, qd</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent prior to any study specific procedures&#xD;
&#xD;
          2. Female and/or male healthy Chinese subjects aged between 18 and 55 inclusive who&#xD;
             reside in Hong Kong&#xD;
&#xD;
          3. Ability to have repeated blood draws or effective venous catheterization&#xD;
&#xD;
          4. Willing to consume food and beverages using a standardized daily diet containing 40 (±&#xD;
             10%) mEq/day sodium and 128 (± 10%) mEq/day potassium provided by the research site&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Participation in another clinical study with an investigational product during the&#xD;
             last 3 months&#xD;
&#xD;
          2. Subjects who were receiving concomitant medications including vitamins, dietary&#xD;
             supplements and herbal preparations within 2 weeks prior to Study Day 1 of the Diet&#xD;
             Run-in Period.&#xD;
&#xD;
          3. Current and/or past history of alcohol abuse within the past year or a positive&#xD;
             results (exceed normal range) of breath test for alcohol abuse&#xD;
&#xD;
          4. Current and/or past history of drugs abuse within the past year or a positive drug&#xD;
             abuse screen, e. g. methylenedioxymethamphetamine, opiate, barbiturates,&#xD;
             benzodiazepines, ketamine, cocaine, amphetamine, methamphetamine, marijuana, and&#xD;
             methadone.&#xD;
&#xD;
          5. Plasma donation within 1 month of screening or any blood donation/blood loss &gt;500 mL&#xD;
             during the 3 months prior to screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>December 18, 2017</last_update_submitted>
  <last_update_submitted_qc>December 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Chinese Subjects, Pharmacodynamic Study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkalemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03283267
org study id: D9483C00001
nct id: NCT03283267
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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.
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).
measure: 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.
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).
measure: 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.
description: Mean change in S-K from the Baseline Period (Day 3 and 4) to the ZS Treatment Period (Day 7 and 8).
measure: Number of subjects with adverse events
time frame: From Day 1 through Follow-up visit
measure: Changes in vital signs
time frame: Through study completion, up to 10 days
measure: Changes in standard Electrocardiograph (ECG ) parameters
time frame: Through study completion, up to 10 days
measure: Changes in standard physical examination parameters including height
time frame: Through study completion, up to 10 days
measure: Changes in standard clinical chemistry lab parameters
time frame: Through study completion, up to 10 days
measure: Changes in standard hematology lab parameters
time frame: Through study completion, up to 10 days
measure: Changes in Serum calcium (S-Ca)
time frame: Through study completion, up to 10 days
measure: Changes in Serum magnesium (S-Mg)
time frame: Through study completion, up to 10 days
measure: Changes in Serum sodium (S-Na)
time frame: Through study completion, up to 10 days
measure: Changes in Serum phosphate (S-PO4)
time frame: Through study completion, up to 10 days
measure: Changes in Serum bicarbonate (S-HCO3)
time frame: Through study completion, up to 10 days
measure: Changes in Blood urea nitrogen (BUN)
time frame: Through study completion, up to 10 days
measure: Number of subjects with Serious adverse events
time frame: Through study completion and follow-up visit, up to 34 Days
arm group label: ZS 5g, qd
arm group type: Experimental
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 group label: ZS 10g, qd
arm group type: Experimental
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: Sodium Zirconium Cyclosilicate (ZS)
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.
arm group label: ZS 10g, qd
arm group label: ZS 5g, qd
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Hyperkalemia
sharing ipd: No