<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/NCT03296800</url>
  </required_header>
  <id_info>
    <org_study_id>THR-1442-C-454</org_study_id>
    <nct_id>NCT03296800</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects</brief_title>
  <official_title>A Phase 1, Open-Label, Non-Randomized, Fixed-Sequence Composite Study to Evaluate the Effects of Probenecid, Rifampin, and Verapamil on the Pharmacokinetics and Pharmacodynamics of Bexagliflozin in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Theracos</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Theracos</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the drug-drug interaction when given the study drug,&#xD;
      bexagliflozin, with three commonly prescribed medications, probenecid, verapamil or rifampin.&#xD;
      The study is to evaluate how safe the study drug is and how well the study drug is tolerated&#xD;
      when taken with probenecid, verapamil or rifampin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, a total of 48 healthy subjects were enrolled and assigned to one of three&#xD;
      groups of 16 subjects. Each group participated in an open-label, non-randomized,&#xD;
      fixed-sequence studies to assess potential interaction of bexagliflozin tablets, 20 mg with&#xD;
      probenecid, rifampin or verapamil.&#xD;
&#xD;
      Sequence 1: Bexagliflozin/probenecid Sixteen healthy subjects were dosed with bexagliflozin,&#xD;
      qd and/or probenecid tablets, 500 mg, bid, in sequential order as follows: on Day 1 subjects&#xD;
      took bexagliflozin; on Days 3 and 4 subjects took probenecid, bid; on Day 5 subjects took one&#xD;
      bexagliflozin, and probenecid, bid; and on Day 6 subjects took probenecid tablets, 500 mg,&#xD;
      bid.&#xD;
&#xD;
      Sequence 2: Bexagliflozin/rifampin Sixteen healthy subjects were dosed with bexagliflozin, qd&#xD;
      and/or 600 mg of rifampin daily in sequential order as follows: on Day 1 subjects took one&#xD;
      bexagliflozin tablet; on Days 3 to 5, subjects took rifampin once daily; on Day 6 subjects&#xD;
      took one bexagliflozin tablet and rifampin; and on Day 7 subjects took rifampin.&#xD;
&#xD;
      Sequence 3: Bexagliflozin/verapamil Sixteen healthy subjects were dosed with bexagliflozin,&#xD;
      and/or verapamil tablets, 120 mg in sequential order as follows: on Day 1 subjects took one&#xD;
      bexagliflozin tablet, on Day 4 subjects took one verapamil tablet, 1 hour before taking a&#xD;
      bexagliflozin tablet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2017</start_date>
  <completion_date type="Actual">December 6, 2017</completion_date>
  <primary_completion_date type="Actual">December 6, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax (Maximum Observed Plasma Concentration)</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax (Time of Maximum Observed Plasma Concentration)</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T1/2 (Apparent Terminal Elimination Half-life)</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity)</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary Glucose Excretion 0-48 hr</measure>
    <time_frame>0 to 48 hours</time_frame>
    <description>Pre-dose urine samples were collected from -12 to 0 h for baseline measurement of pharmacodynamic parameters. Post-dose urine samples were collected without preservative in four batches: 0 to 12 h, 12 to 24 h, 24 to 36h, and 36 to 48 h after dosing. Urine aliquots were prepared from well mixed collections for the assessment of pharmacodynamics.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Bexagliflozin/probenecid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sixteen healthy subjects were dosed with bexagliflozin, qd and/or probenecid tablets, 500 mg, bid, in sequential order as follows: on Day 1 subjects took bexagliflozin; on Days 3 and 4 subjects took probenecid, bid; on Day 5 subjects took one bexagliflozin, and probenecid, bid; and on Day 6 subjects took probenecid tablets, 500 mg, bid.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bexagliflozin/rifampin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sixteen healthy subjects were dosed with bexagliflozin, qd and/or 600 mg of rifampin daily in sequential order as follows: on Day 1 subjects took one bexagliflozin tablet; on Days 3 to 5, subjects took rifampin once daily; on Day 6 subjects took one bexagliflozin tablet and rifampin; and on Day 7 subjects took rifampin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bexagliflozin/verapamil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sixteen healthy subjects were dosed with bexagliflozin, and/or verapamil tablets, 120 mg in sequential order as follows: on Day 1 subjects took one bexagliflozin tablet, on Day 4 subjects took one verapamil tablet, 1 hour before taking a bexagliflozin tablet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bexagliflozin</intervention_name>
    <description>Bexagliflozin 20 mg, tablet; qd</description>
    <arm_group_label>Bexagliflozin/probenecid</arm_group_label>
    <arm_group_label>Bexagliflozin/rifampin</arm_group_label>
    <arm_group_label>Bexagliflozin/verapamil</arm_group_label>
    <other_name>EGT0001442, EGT0001474</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Probenecid</intervention_name>
    <description>Probenecid tablets, 500 mg; bid</description>
    <arm_group_label>Bexagliflozin/probenecid</arm_group_label>
    <other_name>Probalan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifampin</intervention_name>
    <description>Rifampin, 600 mg (2 x 300 mg capsules); qd</description>
    <arm_group_label>Bexagliflozin/rifampin</arm_group_label>
    <other_name>Rifadin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Verapamil</intervention_name>
    <description>Verapamil hydrochloride tablet, 120 mg; qd</description>
    <arm_group_label>Bexagliflozin/verapamil</arm_group_label>
    <other_name>Verelan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Subjects meeting the following Criteria were included::&#xD;
&#xD;
          1. Between 18 and 55 years of age at screening, inclusive, and in good health based on&#xD;
             medical history, physical examination, electrocardiogram and routine laboratory tests.&#xD;
&#xD;
          2. Had a body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2 at screening, inclusive.&#xD;
&#xD;
          3. Abstained from tobacco consumption for at least 3 months prior to screening.&#xD;
&#xD;
          4. Had adequate venous access at multiple sites in both arms.&#xD;
&#xD;
          5. Willing and able to be confined to the clinical research facility as required by the&#xD;
             protocol.&#xD;
&#xD;
          6. Able to comprehend the explanation of the informed consent and willing to provide&#xD;
             written informed consent in accordance with institutional and regulatory guidelines.&#xD;
&#xD;
        Subjects who met any of the following criteria were excluded from the study:&#xD;
&#xD;
          1. A clinically significant history of allergy to drugs or latex (at the Investigator's&#xD;
             discretion.)&#xD;
&#xD;
          2. A history of alcohol or drug dependence in the last 12 months.&#xD;
&#xD;
          3. A history of donation of 400 mL of whole blood within two months, 200 mL of whole&#xD;
             blood within one month, or blood components within 14 days prior to the first dose.&#xD;
&#xD;
          4. A history of prescription or over-the-counter (OTC) drug use within 14 days prior to&#xD;
             the first dose.&#xD;
&#xD;
          5. A history of vitamin preparation or supplement use (including St. John's Wort and&#xD;
             ginseng) within 14 days prior to the first dose.&#xD;
&#xD;
          6. A history of strenuous physical activity within 72 hours prior to dosing.&#xD;
&#xD;
          7. A history of exposure to an investigational drug within 30 days or 7 half-lives of the&#xD;
             investigational drug, whichever was longer, prior to the first dose of investigational&#xD;
             drug in this trial.&#xD;
&#xD;
          8. A history of prior exposure to EGT0001474 or bexagliflozin at any time, or of exposure&#xD;
             to any other SGLT2 inhibitors within 3 months from screening or of participation in&#xD;
             previous bexagliflozin clinical trials.&#xD;
&#xD;
          9. A history of consumption of probenecid, rifampin, or verapamil within 3 months of&#xD;
             screening.&#xD;
&#xD;
         10. A screening ECG that demonstrated any one of the following: heart rate &gt;100 bpm, QRS&#xD;
             &gt;120 msec, QTc &gt;470 msec (corrected by Bazett's formula), PR &gt;220 msec (a subject with&#xD;
             PR &gt;220 msec was generally to be excluded, but exceptions may have been allowed at the&#xD;
             discretion of the Investigator), or any clinically significant arrhythmia.&#xD;
&#xD;
         11. A sitting blood pressure that was above 140/90 mmHg at screening. If the sitting blood&#xD;
             pressure at screening was above 140/90 mmHg, one repeat measurement could have been&#xD;
             taken. Subjects were to be excluded if the repeated sitting blood pressure was above&#xD;
             140/90 mmHg, but exceptions may have been allowed at the discretion of the&#xD;
             Investigator.&#xD;
&#xD;
         12. A positive result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV)&#xD;
             antibody, or for urinary drug or cotinine tests.&#xD;
&#xD;
         13. A history of human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
         14. A history of febrile illness within 5 days prior to the first dose of investigational&#xD;
             drug.&#xD;
&#xD;
         15. A history of vaccination (with the exception of the flu vaccine) within 30 days prior&#xD;
             to the first dose of investigational drug.&#xD;
&#xD;
         16. An estimated glomerular filtration rate (eGFR) &lt; 80 mL/min/1.73 m2 or a history of&#xD;
             kidney transplant.&#xD;
&#xD;
         17. If male, who was not surgically sterile, unwilling to refrain from donating sperm,&#xD;
             and/or unwilling to use appropriate birth control when engaging in sexual intercourse&#xD;
             for a period of 30 days after discharge from the clinic.&#xD;
&#xD;
         18. Female subjects who were surgically sterile (i.e., have undergone partial or full&#xD;
             hysterectomy, or bilateral oophorectomy) or postmenopausal were eligible if they&#xD;
             tested negative on a urine pregnancy test.&#xD;
&#xD;
         19. Evidence of anemia if selected for probenecid study.&#xD;
&#xD;
         20. Evidence of abnormal liver function tests (total bilirubin &gt;1.5 x upper limit of&#xD;
             normal [ULN]); or alanine aminotransferase (ALT) or aspartate aminotransferase (AST)&#xD;
             &gt;2.5 x ULN.&#xD;
&#xD;
         21. If selected for the rifampin study, unwilling to refrain from the use of soft contact&#xD;
             lenses during the study.&#xD;
&#xD;
         22. Unwilling to forgo consumption of alcohol 72 hours pre admission and throughout the&#xD;
             study.&#xD;
&#xD;
         23. Unwilling to forgo consumption of grapefruit and grapefruit products from 7 days prior&#xD;
             to dosing through discharge from the clinic.&#xD;
&#xD;
         24. A history of recurrent yeast or urinary tract infections or any such infections in the&#xD;
             6 months prior to first dose.&#xD;
&#xD;
         25. A history of gout, glucose-6-phosphate dehydrogenase deficiency, or nephrolithiasis if&#xD;
             a candidate for the probenecid study.&#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>
  <overall_official>
    <last_name>Mason Freeman, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Unit</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <results_first_submitted>March 30, 2021</results_first_submitted>
  <results_first_submitted_qc>March 30, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 27, 2021</results_first_posted>
  <last_update_submitted>June 29, 2021</last_update_submitted>
  <last_update_submitted_qc>June 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bexagliflozin</mesh_term>
    <mesh_term>Rifampin</mesh_term>
    <mesh_term>Probenecid</mesh_term>
    <mesh_term>Verapamil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03296800/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03296800/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bexagliflozin, Then Probenecid, Then Bexagliflozin and Probenecid</title>
          <description>Subjects were dosed with bexagliflozin tablets, 20 mg, qd and/or probenecid tablets, 500 mg, bid, in sequential order as follows: on Day 1 subjects took bexagliflozin; on Days 3 and 4 subjects took probenecid, bid; on Day 5 subjects took one bexagliflozin, and probenecid, bid; and on Day 6 subjects took probenecid tablets, 500 mg, bid.</description>
        </group>
        <group group_id="P2">
          <title>Bexagliflozin, Then Rifampin, Then Bexagliflozin and Refampin</title>
          <description>Subjects were dosed with bexagliflozin tablets, 20 mg, qd and/or 600 mg of rifampin daily in sequential order as follows: on Day 1 subjects took one bexagliflozin tablet; on Days 3 to 5, subjects took rifampin once daily; on Day 6 subjects took one bexagliflozin tablet and rifampin; and on Day 7 subjects took rifampin.</description>
        </group>
        <group group_id="P3">
          <title>Bexagliflozin, Then Verapamil and Bexagliflozin</title>
          <description>Subjects were dosed with bexagliflozin tablets, 20 mg, and/or verapamil tablets, 120 mg in sequential order as follows: on Day 1 subjects took one bexagliflozin tablet, on Day 4 subjects took one verapamil tablet, 1 hour before taking a bexagliflozin tablet.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bexagliflozin, Then Probenecid, Then Bexagliflozin and Probenecid</title>
          <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Probenecid: Probenecid tablets, 500 mg; bid</description>
        </group>
        <group group_id="B2">
          <title>Bexagliflozin, Then Rifampin, Then Bexagliflozin and Refampin</title>
          <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd</description>
        </group>
        <group group_id="B3">
          <title>Bexagliflozin, Then Verapamil and Bexagliflozin</title>
          <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Verapamil: Verapamil hydrochloride tablets, 120 mg; qd</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.4" spread="9.69"/>
                    <measurement group_id="B2" value="35.3" spread="10.72"/>
                    <measurement group_id="B3" value="37.8" spread="11.24"/>
                    <measurement group_id="B4" value="37.2" spread="10.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81.3" spread="10.59"/>
                    <measurement group_id="B2" value="74.1" spread="11.31"/>
                    <measurement group_id="B3" value="78.9" spread="9.21"/>
                    <measurement group_id="B4" value="78.7" spread="10.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="170.9" spread="8.28"/>
                    <measurement group_id="B2" value="169.2" spread="8.38"/>
                    <measurement group_id="B3" value="172.1" spread="10.17"/>
                    <measurement group_id="B4" value="170.7" spread="8.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.8" spread="2.73"/>
                    <measurement group_id="B2" value="25.9" spread="3.31"/>
                    <measurement group_id="B3" value="26.7" spread="2.46"/>
                    <measurement group_id="B4" value="27.0" spread="3.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cmax (Maximum Observed Plasma Concentration)</title>
        <description>Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).</description>
        <time_frame>Up to 48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study 1: Bexagliflozin Alone</title>
            <description>Bexagliflozin tablets, 20 mg; qd</description>
          </group>
          <group group_id="O2">
            <title>Study 1: Bexagliflozin and Probenecid</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Probenecid: Probenecid tablets, 500 mg; bid</description>
          </group>
          <group group_id="O3">
            <title>Study 2: Bexagliflozin Alone</title>
            <description>Bexagliflozin tablets, 20 mg; qd</description>
          </group>
          <group group_id="O4">
            <title>Study 2: Bexagliflozin and Rifampin</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd</description>
          </group>
          <group group_id="O5">
            <title>Study 3: Bexagliflozin Alone</title>
            <description>Bexagliflozin tablets, 20 mg; qd</description>
          </group>
          <group group_id="O6">
            <title>Study 3: Bexagliflozin and Verapamil</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Verapamil: Verapamil hydrochloride tablets, 120 mg; qd</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax (Maximum Observed Plasma Concentration)</title>
          <description>Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).</description>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161.675" spread="28.673"/>
                    <measurement group_id="O2" value="193.366" spread="22.098"/>
                    <measurement group_id="O3" value="97.811" spread="53.903"/>
                    <measurement group_id="O4" value="117.001" spread="60.097"/>
                    <measurement group_id="O5" value="159.355" spread="35.396"/>
                    <measurement group_id="O6" value="169.000" spread="24.727"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Geometric LS Mean was used as PK parameters</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The acceptance range for bioequivalence is 80.0 - 125.00%.</non_inferiority_desc>
            <param_type>Point Estimate (%)</param_type>
            <param_value>118.66</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>111.12</ci_lower_limit>
            <ci_upper_limit>126.72</ci_upper_limit>
            <estimate_desc>Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Geometric LS Mean was used as PK parameters</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The acceptance range for bioequivalence is 80.0 - 125.00%.</non_inferiority_desc>
            <param_type>Point Estimate (%)</param_type>
            <param_value>119.62</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>94.39</ci_lower_limit>
            <ci_upper_limit>151.59</ci_upper_limit>
            <other_analysis_desc>Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Geometric LS Mean was used as PK parameters</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The acceptance range for bioequivalence is 80.0 - 125.00%.</non_inferiority_desc>
            <param_type>Point Estimate (%)</param_type>
            <param_value>106.05</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>88.81</ci_lower_limit>
            <ci_upper_limit>126.65</ci_upper_limit>
            <other_analysis_desc>Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax (Time of Maximum Observed Plasma Concentration)</title>
        <description>Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).</description>
        <time_frame>Up to 48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bexagliflozin/Probenecid</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Probenecid: Probenecid tablets, 500 mg; bid</description>
          </group>
          <group group_id="O2">
            <title>Bexagliflozin/Rifampin</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd</description>
          </group>
          <group group_id="O3">
            <title>Bexagliflozin/Verapamil</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Verapamil: Verapamil hydrochloride tablets, 120 mg; qd</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax (Time of Maximum Observed Plasma Concentration)</title>
          <description>Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).</description>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bexagliflozin alone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.000" lower_limit="2.000" upper_limit="4.000"/>
                    <measurement group_id="O2" value="2.000" lower_limit="2.000" upper_limit="4.083"/>
                    <measurement group_id="O3" value="3.0" lower_limit="2.000" upper_limit="8.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bexagliflozin + additional drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.000" lower_limit="2.000" upper_limit="4.017"/>
                    <measurement group_id="O2" value="2.000" lower_limit="1.017" upper_limit="4.000"/>
                    <measurement group_id="O3" value="3.000" lower_limit="2.000" upper_limit="4.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>T1/2 (Apparent Terminal Elimination Half-life)</title>
        <description>Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).</description>
        <time_frame>Up to 48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bexagliflozin/Probenecid</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Probenecid: Probenecid tablets, 500 mg; bid</description>
          </group>
          <group group_id="O2">
            <title>Bexagliflozin/Rifampin</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd</description>
          </group>
          <group group_id="O3">
            <title>Bexagliflozin/Verapamil</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Verapamil: Verapamil hydrochloride tablets, 120 mg; qd</description>
          </group>
        </group_list>
        <measure>
          <title>T1/2 (Apparent Terminal Elimination Half-life)</title>
          <description>Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).</description>
          <units>hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bexagliflozin alone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.090" spread="35.950"/>
                    <measurement group_id="O2" value="12.190" spread="36.966"/>
                    <measurement group_id="O3" value="10.709" spread="44.103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bexagliflozin + additional drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.894" spread="24.806"/>
                    <measurement group_id="O2" value="5.318" spread="49.740"/>
                    <measurement group_id="O3" value="11.675" spread="48.222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity)</title>
        <description>Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).</description>
        <time_frame>Up to 48 hours</time_frame>
        <population>AUC0-t (from time 0 to time T) was used instead of AUC0-inf for Study 2 since AUC0-inf was not reported</population>
        <group_list>
          <group group_id="O1">
            <title>Study 1: Bexagliflozin Alone</title>
            <description>Bexagliflozin tablets, 20 mg; qd</description>
          </group>
          <group group_id="O2">
            <title>Study 1: Bexagliflozin/Probenecid</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Probenecid: Probenecid tablets, 500 mg; bid</description>
          </group>
          <group group_id="O3">
            <title>Study 2: Bexagliflozin Alone</title>
            <description>Bexagliflozin tablets, 20 mg; qd</description>
          </group>
          <group group_id="O4">
            <title>Study 2: Bexagliflozin/Rifampin</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd</description>
          </group>
          <group group_id="O5">
            <title>Study 3: Bexagliflozin Alone</title>
            <description>Bexagliflozin tablets, 20 mg; qd</description>
          </group>
          <group group_id="O6">
            <title>Study 3: Bexagliflozin/Verapamil</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Verapamil: Verapamil hydrochloride tablets, 120 mg; qd</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity)</title>
          <description>Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).</description>
          <population>AUC0-t (from time 0 to time T) was used instead of AUC0-inf for Study 2 since AUC0-inf was not reported</population>
          <units>hr*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1118.741" spread="23.290"/>
                    <measurement group_id="O2" value="1583.188" spread="23.676"/>
                    <measurement group_id="O3" value="698.254" spread="43.945"/>
                    <measurement group_id="O4" value="601.334" spread="49.870"/>
                    <measurement group_id="O5" value="1025.101" spread="25.746"/>
                    <measurement group_id="O6" value="1003.931" spread="21.571"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Geometric LS Mean was used as PK parameters</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The acceptance range for bioequivalence is 80.0 - 125.00%.</non_inferiority_desc>
            <param_type>Point Estimate (%)</param_type>
            <param_value>140.98</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>131.39</ci_lower_limit>
            <ci_upper_limit>151.26</ci_upper_limit>
            <estimate_desc>Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Geometric LS Mean was used as PK parameters</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The acceptance range for bioequivalence is 80.0 - 125.00%.</non_inferiority_desc>
            <param_type>Point Estimate (%)</param_type>
            <param_value>86.12</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>70.24</ci_lower_limit>
            <ci_upper_limit>105.59</ci_upper_limit>
            <estimate_desc>Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Geometric LS Mean was used as PK parameters</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The acceptance range for bioequivalence is 80.0 - 125.00%.</non_inferiority_desc>
            <param_type>Point Estimate (%)</param_type>
            <param_value>97.93</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>90.26</ci_lower_limit>
            <ci_upper_limit>106.26</ci_upper_limit>
            <estimate_desc>Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urinary Glucose Excretion 0-48 hr</title>
        <description>Pre-dose urine samples were collected from -12 to 0 h for baseline measurement of pharmacodynamic parameters. Post-dose urine samples were collected without preservative in four batches: 0 to 12 h, 12 to 24 h, 24 to 36h, and 36 to 48 h after dosing. Urine aliquots were prepared from well mixed collections for the assessment of pharmacodynamics.</description>
        <time_frame>0 to 48 hours</time_frame>
        <population>Only subjects with data in the specific category is included</population>
        <group_list>
          <group group_id="O1">
            <title>Study 1: Bexagliflozin Alone</title>
            <description>Bexagliflozin tablets, 20 mg; qd</description>
          </group>
          <group group_id="O2">
            <title>Bexagliflozin/Probenecid</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Probenecid: Probenecid tablets, 500 mg; bid</description>
          </group>
          <group group_id="O3">
            <title>Study 2: Bexagliflozin Alone</title>
            <description>Bexagliflozin tablets, 20 mg; qd</description>
          </group>
          <group group_id="O4">
            <title>Bexagliflozin/Rifampin</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd</description>
          </group>
          <group group_id="O5">
            <title>Study 3: Bexagliflozin Alone</title>
            <description>Bexagliflozin tablets, 20 mg; qd</description>
          </group>
          <group group_id="O6">
            <title>Bexagliflozin/Verapamil</title>
            <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Verapamil: Verapamil hydrochloride tablets, 120 mg; qd</description>
          </group>
        </group_list>
        <measure>
          <title>Urinary Glucose Excretion 0-48 hr</title>
          <description>Pre-dose urine samples were collected from -12 to 0 h for baseline measurement of pharmacodynamic parameters. Post-dose urine samples were collected without preservative in four batches: 0 to 12 h, 12 to 24 h, 24 to 36h, and 36 to 48 h after dosing. Urine aliquots were prepared from well mixed collections for the assessment of pharmacodynamics.</description>
          <population>Only subjects with data in the specific category is included</population>
          <units>g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose (-12 - 0 hours)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="16"/>
                    <count group_id="O6" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.024"/>
                    <measurement group_id="O2" value="0.47" spread="1.160"/>
                    <measurement group_id="O3" value="0.02" spread="0.014"/>
                    <measurement group_id="O4" value="0.12" spread="0.180"/>
                    <measurement group_id="O5" value="0.02" spread="0.018"/>
                    <measurement group_id="O6" value="1.37" spread="1.476"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 - 12 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="16"/>
                    <count group_id="O6" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.04" spread="5.579"/>
                    <measurement group_id="O2" value="25.90" spread="5.214"/>
                    <measurement group_id="O3" value="31.50" spread="9.272"/>
                    <measurement group_id="O4" value="31.40" spread="7.363"/>
                    <measurement group_id="O5" value="31.14" spread="5.814"/>
                    <measurement group_id="O6" value="31.46" spread="14.835"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 - 24 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="16"/>
                    <count group_id="O6" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.28" spread="7.347"/>
                    <measurement group_id="O2" value="20.92" spread="4.358"/>
                    <measurement group_id="O3" value="19.43" spread="6.863"/>
                    <measurement group_id="O4" value="15.72" spread="7.259"/>
                    <measurement group_id="O5" value="22.30" spread="3.933"/>
                    <measurement group_id="O6" value="20.51" spread="5.940"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 - 36 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="16"/>
                    <count group_id="O6" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.04" spread="7.136"/>
                    <measurement group_id="O2" value="22.10" spread="6.826"/>
                    <measurement group_id="O3" value="21.51" spread="7.668"/>
                    <measurement group_id="O4" value="16.32" spread="6.370"/>
                    <measurement group_id="O5" value="24.54" spread="6.517"/>
                    <measurement group_id="O6" value="20.94" spread="6.745"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 - 48 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="16"/>
                    <count group_id="O6" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.15" spread="5.447"/>
                    <measurement group_id="O2" value="9.53" spread="3.114"/>
                    <measurement group_id="O3" value="6.99" spread="3.440"/>
                    <measurement group_id="O4" value="3.41" spread="2.318"/>
                    <measurement group_id="O5" value="11.31" spread="4.997"/>
                    <measurement group_id="O6" value="4.78" spread="2.941"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 - 24 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="16"/>
                    <count group_id="O6" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.73" spread="9.125"/>
                    <measurement group_id="O2" value="46.82" spread="8.530"/>
                    <measurement group_id="O3" value="50.93" spread="15.606"/>
                    <measurement group_id="O4" value="47.12" spread="13.790"/>
                    <measurement group_id="O5" value="53.44" spread="8.712"/>
                    <measurement group_id="O6" value="51.97" spread="13.658"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 - 48 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="16"/>
                    <count group_id="O6" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.67" spread="16.083"/>
                    <measurement group_id="O2" value="78.44" spread="15.653"/>
                    <measurement group_id="O3" value="79.43" spread="24.490"/>
                    <measurement group_id="O4" value="66.86" spread="19.564"/>
                    <measurement group_id="O5" value="89.29" spread="16.461"/>
                    <measurement group_id="O6" value="77.69" spread="16.497"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Study 1: Bexagliflozin Alone</title>
          <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd</description>
        </group>
        <group group_id="E2">
          <title>Study 1: Bexagliflozin and Probenecid</title>
          <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Probenecid: Probenecid tablets, 500 mg; bid</description>
        </group>
        <group group_id="E3">
          <title>Study 2: Bexagliflozin Alone</title>
          <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd</description>
        </group>
        <group group_id="E4">
          <title>Study 2: Bexagliflozin and Rrifampin</title>
          <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd</description>
        </group>
        <group group_id="E5">
          <title>Study 3: Bexagliflozin Alone</title>
          <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd</description>
        </group>
        <group group_id="E6">
          <title>Study 3: Bexagliflozin and Verapamil</title>
          <description>Bexagliflozin: Bexagliflozin tablets, 20 mg; qd&#xD;
Verapamil: Verapamil hydrochloride tablets, 120 mg; qd</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Gastrointestinal sounds abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Investigator has no right to publish the trial results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Albert Collinson</name_or_title>
      <organization>Theracos Sub, LLC</organization>
      <phone>(508) 688-4221</phone>
      <email>acollinson@theracos.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03296800
org study id: THR-1442-C-454
nct id: NCT03296800
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to examine the drug-drug interaction when given the study drug,
      bexagliflozin, with three commonly prescribed medications, probenecid, verapamil or rifampin.
      The study is to evaluate how safe the study drug is and how well the study drug is tolerated
      when taken with probenecid, verapamil or rifampin.
In this study, a total of 48 healthy subjects were enrolled and assigned to one of three
      groups of 16 subjects. Each group participated in an open-label, non-randomized,
      fixed-sequence studies to assess potential interaction of bexagliflozin tablets, 20 mg with
      probenecid, rifampin or verapamil.

      Sequence 1: Bexagliflozin/probenecid Sixteen healthy subjects were dosed with bexagliflozin,
      qd and/or probenecid tablets, 500 mg, bid, in sequential order as follows: on Day 1 subjects
      took bexagliflozin; on Days 3 and 4 subjects took probenecid, bid; on Day 5 subjects took one
      bexagliflozin, and probenecid, bid; and on Day 6 subjects took probenecid tablets, 500 mg,
      bid.

      Sequence 2: Bexagliflozin/rifampin Sixteen healthy subjects were dosed with bexagliflozin, qd
      and/or 600 mg of rifampin daily in sequential order as follows: on Day 1 subjects took one
      bexagliflozin tablet; on Days 3 to 5, subjects took rifampin once daily; on Day 6 subjects
      took one bexagliflozin tablet and rifampin; and on Day 7 subjects took rifampin.

      Sequence 3: Bexagliflozin/verapamil Sixteen healthy subjects were dosed with bexagliflozin,
      and/or verapamil tablets, 120 mg in sequential order as follows: on Day 1 subjects took one
      bexagliflozin tablet, on Day 4 subjects took one verapamil tablet, 1 hour before taking a
      bexagliflozin tablet.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax (Maximum Observed Plasma Concentration)
time frame: Up to 48 hours
description: Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).
measure: Tmax (Time of Maximum Observed Plasma Concentration)
time frame: Up to 48 hours
description: Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).
measure: T1/2 (Apparent Terminal Elimination Half-life)
time frame: Up to 48 hours
description: Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).
measure: AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity)
time frame: Up to 48 hours
description: Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).
measure: Urinary Glucose Excretion 0-48 hr
time frame: 0 to 48 hours
description: Pre-dose urine samples were collected from -12 to 0 h for baseline measurement of pharmacodynamic parameters. Post-dose urine samples were collected without preservative in four batches: 0 to 12 h, 12 to 24 h, 24 to 36h, and 36 to 48 h after dosing. Urine aliquots were prepared from well mixed collections for the assessment of pharmacodynamics.
arm group label: Bexagliflozin/probenecid
arm group type: Experimental
description: Sixteen healthy subjects were dosed with bexagliflozin, qd and/or probenecid tablets, 500 mg, bid, in sequential order as follows: on Day 1 subjects took bexagliflozin; on Days 3 and 4 subjects took probenecid, bid; on Day 5 subjects took one bexagliflozin, and probenecid, bid; and on Day 6 subjects took probenecid tablets, 500 mg, bid.
arm group label: Bexagliflozin/rifampin
arm group type: Experimental
description: Sixteen healthy subjects were dosed with bexagliflozin, qd and/or 600 mg of rifampin daily in sequential order as follows: on Day 1 subjects took one bexagliflozin tablet; on Days 3 to 5, subjects took rifampin once daily; on Day 6 subjects took one bexagliflozin tablet and rifampin; and on Day 7 subjects took rifampin.
arm group label: Bexagliflozin/verapamil
arm group type: Experimental
description: Sixteen healthy subjects were dosed with bexagliflozin, and/or verapamil tablets, 120 mg in sequential order as follows: on Day 1 subjects took one bexagliflozin tablet, on Day 4 subjects took one verapamil tablet, 1 hour before taking a bexagliflozin tablet.
intervention type: Drug
intervention name: Bexagliflozin
description: Bexagliflozin 20 mg, tablet; qd
arm group label: Bexagliflozin/probenecid
arm group label: Bexagliflozin/rifampin
arm group label: Bexagliflozin/verapamil
other name: EGT0001442, EGT0001474
intervention type: Drug
intervention name: Probenecid
description: Probenecid tablets, 500 mg; bid
arm group label: Bexagliflozin/probenecid
other name: Probalan
intervention type: Drug
intervention name: Rifampin
description: Rifampin, 600 mg (2 x 300 mg capsules); qd
arm group label: Bexagliflozin/rifampin
other name: Rifadin
intervention type: Drug
intervention name: Verapamil
description: Verapamil hydrochloride tablet, 120 mg; qd
arm group label: Bexagliflozin/verapamil
other name: Verelan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mason Freeman, M.D.
role: Study Director
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Bexagliflozin
mesh term: Rifampin
mesh term: Probenecid
mesh term: Verapamil
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 