<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/NCT02249936</url>
  </required_header>
  <id_info>
    <org_study_id>D5611C00002</org_study_id>
    <nct_id>NCT02249936</nct_id>
  </id_info>
  <brief_title>A Phase 1 Study to Examine the Pharmacodynamics of Different AZD1722 Formulations</brief_title>
  <official_title>A Phase 1, Single-Center, Randomized, 3-Way Cross-Over, Open Label Study to Evaluate the Pharmacodynamics of Different Formulations of AZD1722 in Healthy Volunteers Taking Omeprazole</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ardelyx</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ardelyx</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics&#xD;
      of different formulations of AZD1722 in healthy male and female subjects taking Omeprazole.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>8 days</time_frame>
    <description>Measurement of safety laboratories, ECGs, vitals signs and physical exams</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sodium levels in stool and urine</measure>
    <time_frame>8 days</time_frame>
    <description>Pharmacodynamic activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma drug concentration to calculate AUC</measure>
    <time_frame>8 days</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>AZD1722 HCl Capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 mg bid AZD1722 HCl and 20 mg bid Omeprazole</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AZD1722 HCl Tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 mg bid AZD1722 HCl and 20 mg bid Omeprazole</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AZD1722 Free-base Tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 mg bid AZD1722 and 20 mg bid Omeprazole</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD1722</intervention_name>
    <arm_group_label>AZD1722 Free-base Tablet</arm_group_label>
    <arm_group_label>AZD1722 HCl Capsule</arm_group_label>
    <arm_group_label>AZD1722 HCl Tablet</arm_group_label>
    <other_name>Tenapanor</other_name>
    <other_name>RDX5791</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omeprazole</intervention_name>
    <arm_group_label>AZD1722 Free-base Tablet</arm_group_label>
    <arm_group_label>AZD1722 HCl Capsule</arm_group_label>
    <arm_group_label>AZD1722 HCl Tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy man or woman&#xD;
&#xD;
          -  Body mass index between 18 and 29.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis or treatment of any clinically symptomatic biochemical or structural&#xD;
             abnormality of the gastrointestinal (GI) tract&#xD;
&#xD;
          -  Any surgery on the small intestine or colon, excluding appendectomy or cholecystectomy&#xD;
             or any other condition known to interfere with absorption, distribution, metabolism or&#xD;
             excretion of drugs&#xD;
&#xD;
          -  Clinical evidence of significant cardiovascular, respiratory, renal, hepatic,&#xD;
             gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease,&#xD;
             or any condition that may interfere with the subject successfully completing the trial&#xD;
             or that would present a safety risk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David P Rosenbaum, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Ardelyx, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ICON Development Solutions</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Omeprazole</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02249936
org study id: D5611C00002
nct id: NCT02249936
lead sponsor: 
collaborator: 
has dmc: No
The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics
      of different formulations of AZD1722 in healthy male and female subjects taking Omeprazole.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of patients with adverse events
time frame: 8 days
description: Measurement of safety laboratories, ECGs, vitals signs and physical exams
measure: Sodium levels in stool and urine
time frame: 8 days
description: Pharmacodynamic activity
measure: Plasma drug concentration to calculate AUC
time frame: 8 days
description: Pharmacokinetics
arm group label: AZD1722 HCl Capsule
arm group type: Experimental
description: 15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
arm group label: AZD1722 HCl Tablet
arm group type: Experimental
description: 15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
arm group label: AZD1722 Free-base Tablet
arm group type: Experimental
description: 15 mg bid AZD1722 and 20 mg bid Omeprazole
intervention type: Drug
intervention name: AZD1722
arm group label: AZD1722 Free-base Tablet
arm group label: AZD1722 HCl Capsule
arm group label: AZD1722 HCl Tablet
other name: Tenapanor
other name: RDX5791
intervention type: Drug
intervention name: Omeprazole
arm group label: AZD1722 Free-base Tablet
arm group label: AZD1722 HCl Capsule
arm group label: AZD1722 HCl Tablet
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David P Rosenbaum, Ph.D.
role: Study Director
affiliation: Ardelyx, Inc
facility: 
country: United States
responsible party type: Sponsor
mesh term: Omeprazole