<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/NCT02226783</url>
  </required_header>
  <id_info>
    <org_study_id>D5611C00003</org_study_id>
    <nct_id>NCT02226783</nct_id>
  </id_info>
  <brief_title>D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy Subjects</brief_title>
  <official_title>Phase I Study in Healthy Subjects to Evaluate the Pharmacodynamics (PD) of AZD1722 Given With and Without Food (Part A) and a 2-way Crossover to Evaluate the PD of AZD1722 Given as a Free-base Tablet With and Without Omeprazole (Part B)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ardelyx</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ardelyx</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study to evaluate the effect of intake of food in comparison to fasting condition on&#xD;
      pharmacodynamics of AZD1722 following a twice-daily administration of AZD1722 tablet&#xD;
      formulation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase I, Open-label, Randomized, Single-center, 3-way Crossover Study in Healthy Subjects&#xD;
      to Evaluate the Pharmacodynamics Effects of AZD1722 Administered With and Without Food (Part&#xD;
      A) plus a 2-way Crossover in Subjects to Evaluate the Pharmacodynamic Effect of AZD1722&#xD;
      Administered as an AZD1722 Free-base Tablet with and without Omeprazole (Part B)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacodynamic:- To evaluate the effect of intake of food in comparison to fasting condition on PD of AZD1722 following a twice-daily administration of AZD1722 tablet formulation</measure>
    <time_frame>Stool samples will be collected over 24 hr periods from day -2 to Day 17</time_frame>
    <description>Sodium and phosphorus content in stool collected over 24-hour intervals</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic:- To evaluate the effect of intake of food in comparison to fasting condition on PD of AZD1722 following twice-daily administration of an AZD1722 tablet formulation</measure>
    <time_frame>Stool samples will be collected over 24 hr periods from day -2 to Day 17</time_frame>
    <description>Stool consistency, weight, and frequency measured on a daily basis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic:- To evaluate the effect of intake of food in comparison to fasting condition on PD ofAZD1722 following twice-daily administration of an AZD1722 tablet formulation</measure>
    <time_frame>Urine will be collected in 24 hour intervals from Day -2 to Day 17</time_frame>
    <description>Urinary sodium and phosphorus content over 24-hour intervals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic: To evaluate the plasma concentrations of AZD1722</measure>
    <time_frame>Predose, 1, 2, and 4 hours post morning dose for measurement of AZD1722 in plasma will be taken on days 1, 4, 7, 10, 13, and 16</time_frame>
    <description>AZD1722 plasma concentrations</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety:- To evaluate the safety of AZD1722</measure>
    <time_frame>Safety assessments will be performed throughout the study from Baseline to final follow-up visit (Day-2 to Day 26)</time_frame>
    <description>Adverse events, vital signs, physical examinations, ECGs, and laboratory assessments (chemistry, hematology, and urinalysis)</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory:-To evaluate the effect of high and low gastric pH on the PD of AZD1722 following twice daily administration of an AZD1722 free-base tablet formulation given with and without omeprazole</measure>
    <time_frame>Stool and urine samples will be collected over 24 hr periods from day -2 to Day 14</time_frame>
    <description>Stool sodium and phosphorus content; stool frequency, weight, and consistency; and urine sodium and phosphorus content assessed over 24-hour intervals</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Healthy Volunteers Food Interaction Study</condition>
  <arm_group>
    <arm_group_label>Treatment A AZD1722 salt tablet (fasted)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A-Treatment A: morning dose of AZD1722 salt tablet 5 to 10 minutes before start of intake of breakfast; evening dose 5 to 10 minutes before start of intake of dinner</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B AZD1722 salt tablet (fed)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A Treatment B: morning dose of AZD1722 salt tablet 30 minutes after start of intake of breakfast; evening dose 30 minutes after start of intake of dinner</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C AZD1722 salt tablet (fasted)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A Treatment C: morning dose AZD1722 HCl tablet then breakfast served 1 hour after dosing; evening dose 3 hours after start of intake of dinner and 1 hour before the next meal consumption</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treat D AZD1722 free-base tablet (fast)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part B Treatment D: morning dose of AZD1722 free-base tablet administered 5 to 10 minutes before the start of intake of breakfast and evening dose 5 to 10 minutes before start of intake of dinner</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treat E AZD1722 free-base+Omeprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part B Treatment E: morning dose of AZD1722 free base tablet administered 5 to 10 minutes before start of intake of breakfast and evening dose 5 to 10 minutes before start of intake of dinner; omeprazole was administered twice daily from Days -5 to -1 or Days 5 to 9 (depending on assigned treatment period), 1 hour before breakfast and dinner, and from Days 1 to 4 or Days 10 to 13, 1 hour prior to the administration of AZD1722</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD1722 salt tablet</intervention_name>
    <description>AZD1722 will be administered as 14 mg (salt tablet). tablet for oral use. Subjects will receive a 14 mg tablet in the morning and evening on Days 1 to 4 (Period 1), Days 7 to 10 (Period 2), and Days 13 to 16 (Period 3).</description>
    <arm_group_label>Treatment A AZD1722 salt tablet (fasted)</arm_group_label>
    <arm_group_label>Treatment B AZD1722 salt tablet (fed)</arm_group_label>
    <arm_group_label>Treatment C AZD1722 salt tablet (fasted)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD1722 free base tablet</intervention_name>
    <description>AZD1722 will be given as four 14 mg free-base tablets (56mg) in the morning and evening on Days 1 to 4 (Period 1) and Days 10 to 13 (Period 2).</description>
    <arm_group_label>Treat D AZD1722 free-base tablet (fast)</arm_group_label>
    <arm_group_label>Treat E AZD1722 free-base+Omeprazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD1722 free base tablet + Omeprazole</intervention_name>
    <description>AZD1722 free base tablet administered 5 to 10 minutes before intake of breakfast and evening dose 5 to 10 minutes before start of intake of dinner; omeprazole was administered twice daily from Days -5 to -1 or Days 5 to 9 (depending on assigned treatment period), 1 hour before breakfast and dinner, and from Days 1 to 4 or Days 10 to 13, 1 hour prior to the administration of AZD1722</description>
    <arm_group_label>Treat E AZD1722 free-base+Omeprazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male and female volunteers aged 18 to 65 years&#xD;
&#xD;
          2. Females of childbearing potential had to have a negative pregnancy test and females of&#xD;
             childbearing potential included in the study had to use 2 effective methods of&#xD;
             avoiding pregnancy, females of nonchildbearing potential to fulfill 1 of the following&#xD;
             criteria:&#xD;
&#xD;
               1. Postmenopausal, defined as amenorrhea for at least 12 months or more following&#xD;
                  cessation of all exogenous hormonal treatment and luteinizing hormone (LH) and&#xD;
                  follicle-stimulating hormone (FSH) levels in the postmenopausal range&#xD;
&#xD;
               2. Documentation of irreversible surgical sterilization by hysterectomy, tubal&#xD;
                  occlusion, bilateral oophorectomy, or bilateral salpingectomy but not tubal&#xD;
                  ligation&#xD;
&#xD;
          3. Had a body mass index (BMI) of 18 and 30 kg/m2, inclusive, and weight at least 50 kg&#xD;
             and no more than 100 kg&#xD;
&#xD;
          4. Regular bowel habits of at least 1 stool portion per day.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) History of clinically-significant disease or disorder (2) History or presence of GI,&#xD;
        hepatic, or renal disease, including GI surgery, or any condition known to interfere with&#xD;
        absorption, distribution, metabolism, or excretion of drugs. (3) Any clinically significant&#xD;
        illness, medical/surgical procedure, or trauma within 4 weeks (4) any&#xD;
        clinically-significant abnormalities in clinical chemistry, hematology, or urinalysis.&#xD;
&#xD;
        (5) Abnormal vital signs after a 10-minute supine rest, any clinically-significant&#xD;
        abnormalities in rhythm, conduction, or morphology of resting ECG (6) Prolonged QTcF&#xD;
        greater than 450 ms or shortened QTcF less than 340 ms or family history of long QT&#xD;
        syndrome.&#xD;
&#xD;
        (7) Loose stools (Bristol Stool Form Score [BSFS] of 6 or 7) 2 or more days during the 7&#xD;
        days prior to randomization (8) Use of medications that are known to affect stool&#xD;
        consistency and/or GI motility, including fiber supplements, probiotic supplements,&#xD;
        probiotic supplements in medication form, antidiarrheals, prokinetic drugs, enemas,&#xD;
        probiotic medications or supplements (ie, Activia®); or salt or electrolyte supplements&#xD;
        containing sodium, potassium, chloride, or bicarbonate formulations during the past 7 days&#xD;
        before randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Mathews, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quintiles Phase I Services, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>KS 66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>September 18, 2015</last_update_submitted>
  <last_update_submitted_qc>September 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase I</keyword>
  <keyword>Healthy subjects</keyword>
  <keyword>PK</keyword>
  <keyword>PD</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/NCT02226783
org study id: D5611C00003
nct id: NCT02226783
lead sponsor: 
has dmc: No
Study to evaluate the effect of intake of food in comparison to fasting condition on
      pharmacodynamics of AZD1722 following a twice-daily administration of AZD1722 tablet
      formulation
A Phase I, Open-label, Randomized, Single-center, 3-way Crossover Study in Healthy Subjects
      to Evaluate the Pharmacodynamics Effects of AZD1722 Administered With and Without Food (Part
      A) plus a 2-way Crossover in Subjects to Evaluate the Pharmacodynamic Effect of AZD1722
      Administered as an AZD1722 Free-base Tablet with and without Omeprazole (Part B)
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacodynamic:- To evaluate the effect of intake of food in comparison to fasting condition on PD of AZD1722 following a twice-daily administration of AZD1722 tablet formulation
time frame: Stool samples will be collected over 24 hr periods from day -2 to Day 17
description: Sodium and phosphorus content in stool collected over 24-hour intervals
measure: Pharmacodynamic:- To evaluate the effect of intake of food in comparison to fasting condition on PD of AZD1722 following twice-daily administration of an AZD1722 tablet formulation
time frame: Stool samples will be collected over 24 hr periods from day -2 to Day 17
description: Stool consistency, weight, and frequency measured on a daily basis
measure: Pharmacodynamic:- To evaluate the effect of intake of food in comparison to fasting condition on PD ofAZD1722 following twice-daily administration of an AZD1722 tablet formulation
time frame: Urine will be collected in 24 hour intervals from Day -2 to Day 17
description: Urinary sodium and phosphorus content over 24-hour intervals
measure: Pharmacokinetic: To evaluate the plasma concentrations of AZD1722
time frame: Predose, 1, 2, and 4 hours post morning dose for measurement of AZD1722 in plasma will be taken on days 1, 4, 7, 10, 13, and 16
description: AZD1722 plasma concentrations
measure: Safety:- To evaluate the safety of AZD1722
time frame: Safety assessments will be performed throughout the study from Baseline to final follow-up visit (Day-2 to Day 26)
description: Adverse events, vital signs, physical examinations, ECGs, and laboratory assessments (chemistry, hematology, and urinalysis)
measure: Exploratory:-To evaluate the effect of high and low gastric pH on the PD of AZD1722 following twice daily administration of an AZD1722 free-base tablet formulation given with and without omeprazole
time frame: Stool and urine samples will be collected over 24 hr periods from day -2 to Day 14
description: Stool sodium and phosphorus content; stool frequency, weight, and consistency; and urine sodium and phosphorus content assessed over 24-hour intervals
arm group label: Treatment A AZD1722 salt tablet (fasted)
arm group type: Experimental
description: Part A-Treatment A: morning dose of AZD1722 salt tablet 5 to 10 minutes before start of intake of breakfast; evening dose 5 to 10 minutes before start of intake of dinner
arm group label: Treatment B AZD1722 salt tablet (fed)
arm group type: Experimental
description: Part A Treatment B: morning dose of AZD1722 salt tablet 30 minutes after start of intake of breakfast; evening dose 30 minutes after start of intake of dinner
arm group label: Treatment C AZD1722 salt tablet (fasted)
arm group type: Experimental
description: Part A Treatment C: morning dose AZD1722 HCl tablet then breakfast served 1 hour after dosing; evening dose 3 hours after start of intake of dinner and 1 hour before the next meal consumption
arm group label: Treat D AZD1722 free-base tablet (fast)
arm group type: Experimental
description: Part B Treatment D: morning dose of AZD1722 free-base tablet administered 5 to 10 minutes before the start of intake of breakfast and evening dose 5 to 10 minutes before start of intake of dinner
arm group label: Treat E AZD1722 free-base+Omeprazole
arm group type: Experimental
description: Part B Treatment E: morning dose of AZD1722 free base tablet administered 5 to 10 minutes before start of intake of breakfast and evening dose 5 to 10 minutes before start of intake of dinner; omeprazole was administered twice daily from Days -5 to -1 or Days 5 to 9 (depending on assigned treatment period), 1 hour before breakfast and dinner, and from Days 1 to 4 or Days 10 to 13, 1 hour prior to the administration of AZD1722
intervention type: Drug
intervention name: AZD1722 salt tablet
description: AZD1722 will be administered as 14 mg (salt tablet). tablet for oral use. Subjects will receive a 14 mg tablet in the morning and evening on Days 1 to 4 (Period 1), Days 7 to 10 (Period 2), and Days 13 to 16 (Period 3).
arm group label: Treatment A AZD1722 salt tablet (fasted)
arm group label: Treatment B AZD1722 salt tablet (fed)
arm group label: Treatment C AZD1722 salt tablet (fasted)
intervention type: Drug
intervention name: AZD1722 free base tablet
description: AZD1722 will be given as four 14 mg free-base tablets (56mg) in the morning and evening on Days 1 to 4 (Period 1) and Days 10 to 13 (Period 2).
arm group label: Treat D AZD1722 free-base tablet (fast)
arm group label: Treat E AZD1722 free-base+Omeprazole
intervention type: Drug
intervention name: AZD1722 free base tablet + Omeprazole
description: AZD1722 free base tablet administered 5 to 10 minutes before intake of breakfast and evening dose 5 to 10 minutes before start of intake of dinner; omeprazole was administered twice daily from Days -5 to -1 or Days 5 to 9 (depending on assigned treatment period), 1 hour before breakfast and dinner, and from Days 1 to 4 or Days 10 to 13, 1 hour prior to the administration of AZD1722
arm group label: Treat E AZD1722 free-base+Omeprazole
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Mathews, MD
role: Principal Investigator
affiliation: Quintiles Phase I Services, LLC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Omeprazole