<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/NCT03776539</url>
  </required_header>
  <id_info>
    <org_study_id>EL-008</org_study_id>
    <nct_id>NCT03776539</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02</brief_title>
  <official_title>A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eloxx Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Syneos Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Eloxx Pharmaceuticals, Inc.</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>
      Phase 1 - Pharmacokinetics in Patients with Impaired Renal Function&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a two-center, Phase 1, open-label, single-dose, one-period, four-parallel-group,&#xD;
      PK study in subjects with various severities of renal dysfunction and healthy volunteers.&#xD;
&#xD;
      Subjects will be categorized in 4 groups:&#xD;
&#xD;
      Group 1: subjects with mild renal impairment Group 2: subjects with moderate renal impairment&#xD;
      Group 3: subjects with severe renal impairment Group 4 (control group): subjects with normal&#xD;
      renal function&#xD;
&#xD;
      The mild (group 1) and moderate (group 2) patients with renal disease will be dosed first, in&#xD;
      a parallel fashion. At this point, interim PK analyses will be performed and a safety&#xD;
      committee composed of Sponsor and Contract Research Organization (CRO) members will jointly&#xD;
      review the PK data before dosing the patients with severe renal disease (group 3). Control&#xD;
      subjects (group 4) will be recruited after the recruitment of groups 1 to 3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2019</start_date>
  <completion_date type="Actual">August 7, 2019</completion_date>
  <primary_completion_date type="Actual">July 30, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Subjects will be categorized in 4 groups:&#xD;
Group 1: subjects with mild renal impairment&#xD;
Group 2: subjects with moderate renal impairment&#xD;
Group 3: subjects with severe renal impairment&#xD;
Group 4 (control group): subjects with normal renal function</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic Parameters- Plasma AUC0-24</measure>
    <time_frame>0.25, 0.5, 0.75, 1, 2, 4, 6, 12, and 24 hours after dosing</time_frame>
    <description>Area under the curve (AUC0-24) of ELX-02 plasma concentration following a single subcutaneous (SC) dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Parameters- Plasma Cmax</measure>
    <time_frame>0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 36, 48, 72, and 168 (Day 8) hours after dosing</time_frame>
    <description>Peak Plasma Concentration (Cmax) of ELX-02 following a single subcutaneous (SC) dose in subjects with normal renal function, mild, moderate, or severe renal impairment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-inf</measure>
    <time_frame>0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 36, 48, 72, and 168 (Day 8) hours after dosing</time_frame>
    <description>Area under the curve (AUC0-inf) of ELX-02 plasma concentration following a single subcutaneous (SC) dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Parameters - Plasma Tmax</measure>
    <time_frame>0.25, 0.5, 0.75, 1, 2, 4, 6, 12, and 24 hours after dosing.</time_frame>
    <description>Time to maximum concentration (Tmax) of ELX-02 plasma concentration following a single subcutaneous (SC) dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine Pharmacokinetics Parameter - Ae0-t</measure>
    <time_frame>Pre-dose (first void in the morning of Day 1), 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36, 36-48, and 48-72 hours post-dose</time_frame>
    <description>Cumulative amount of unchanged drug excreted into urine (Ae0-t) of ELX-02 following a single subcutaneous (SC) dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine Pharmacokinetic Parameter - Rmax</measure>
    <time_frame>Pre-dose (first void in the morning of Day 1), 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36, 36-48, and 48-72 hours post-dose</time_frame>
    <description>Maximum rate of urinary extraction (Rmax) of ELX-02 following a single subcutaneous (SC) dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients Reporting Treatment-Emergent Adverse Events (TEAEs) [Safety]</measure>
    <time_frame>1-8 days</time_frame>
    <description>TEAEs are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the study treatment</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Impaired Renal Function</condition>
  <arm_group>
    <arm_group_label>ELX-02</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: ELX-02</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ELX-02</intervention_name>
    <description>ELX-02 is a synthetic, designer eukaryotic ribosomal specific glycoside (ERSG) optimized as a translational read-through drug. All groups will get the same treatment.</description>
    <arm_group_label>ELX-02</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, non-smoker and/or light smoker&#xD;
&#xD;
          2. Have a diagnosis of renal impairment that has been stable, without any significant&#xD;
             change in overall disease status in the last 3 months prior to screening.&#xD;
&#xD;
          3. Have an estimated glomerular filtration rate (eGFR) expressed in mL/min/1.73 m2&#xD;
             (Modification of Diet in Renal Disease 4-variable [MDRD4] equation) at screening&#xD;
             within the range of:&#xD;
&#xD;
               1. Group 1 - Mild Group: 60 - 89 mL/min/1.73 m2;&#xD;
&#xD;
               2. Group 2 - Moderate Group: 30 - 59 mL/min/1.73 m2;&#xD;
&#xD;
               3. Group 3 - Severe Group: &lt; 30 mL/min/1.73 m2 not requiring dialysis. eGFR results&#xD;
                  that are deemed inconsistent with the usual stage of renal impairment may be&#xD;
                  repeated. Subjects are categorized into severity group at screening. If the eGFR&#xD;
                  scores change on Day-1 or other visit due to a non-clinically significant change&#xD;
                  in clinical status or laboratory result, the subject keeps the original severity&#xD;
                  group.&#xD;
&#xD;
          4. Subject may have stable treated medical illnesses and underlying diseases producing&#xD;
             the renal impairment such as diabetes, hypertension, or cardiovascular disease,&#xD;
             providing that, in the opinion of the PI, the disease is stable.&#xD;
&#xD;
          5. Have normal or non-clinically significant findings at physical examination, vital&#xD;
             signs and electrocardiogram (ECG) and normal limits or non-clinically significant&#xD;
             deviations in clinical laboratory evaluations at screening.&#xD;
&#xD;
          6. Other than renal impairment, have no other conditions which may significantly impact&#xD;
             study drug absorption or metabolism.&#xD;
&#xD;
          7. Stable medical regimen, deemed not to interact with study drug PK, for 14 days prior&#xD;
             to dosing, except for routine daily management of electrolytes (e.g. potassium),&#xD;
             acid-base, or other associated disorders expected in patients with renal impairment.&#xD;
&#xD;
          8. Females of childbearing potential who are sexually active with a non-sterile male&#xD;
             partner (sterile male partners are defined as men vasectomized since at least 6&#xD;
             months) must be willing to use acceptable contraceptive method throughout the study&#xD;
             and for 30 days after study drug administration.&#xD;
&#xD;
          9. Male subjects who are not vasectomized for at least 6 months, and who are sexually&#xD;
             active with a non-sterile female partner (sterile female partners include&#xD;
             post-menopausal females and surgically sterile females) must be willing to use&#xD;
             acceptable contraceptive method from dosing until at least 90 days after study drug&#xD;
             administration.&#xD;
&#xD;
         10. Male subjects (including men who have had vasectomy) with a pregnant partner must&#xD;
             agree to use a condom from dosing until at least 90 days after study drug&#xD;
             administration.&#xD;
&#xD;
         11. Male subjects must be willing not to donate sperm until 90 days following study drug&#xD;
             administration.&#xD;
&#xD;
         12. Able to understand and willing to sign the Informed Consent Form (ICF) and comply with&#xD;
             the study restrictions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unstable renal function or acute exacerbation of renal disease within 14 days of study&#xD;
             drug administration, as indicated by recent history or worsening of clinical and/or&#xD;
             laboratory signs of renal impairment.&#xD;
&#xD;
          2. Has a functioning renal transplant.&#xD;
&#xD;
          3. Major illness or surgery within 4 weeks prior to dosing.&#xD;
&#xD;
          4. Clinically significant unstable medical condition or history of any illness that may&#xD;
             increase the risk associated with study participation or investigational drug&#xD;
             administration or may interfere with the interpretation of study results and would&#xD;
             make the subject inappropriate for entry into this study.&#xD;
&#xD;
          5. Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at&#xD;
             screening.&#xD;
&#xD;
          6. History of allergic reactions, hypersensitivity or toxic reactions to aminoglycosides.&#xD;
&#xD;
          7. History of anaphylaxis.&#xD;
&#xD;
          8. Supine 12-lead ECG abnormalities at screening considered clinically significant.&#xD;
&#xD;
          9. Clinically significant vital sign abnormalities at screening.&#xD;
&#xD;
         10. History of significant drug or alcohol abuse within six months prior to screening.&#xD;
&#xD;
         11. Participation in a clinical research study involving the administration of an&#xD;
             investigational or marketed drug or device within 30 days (or 5 half-lives, whichever&#xD;
             is longer) prior to dosing, administration of a biological product in the context of a&#xD;
             clinical research study within 90 days prior to dosing, or concomitant participation&#xD;
             in an investigational study involving no drug or device administration.&#xD;
&#xD;
         12. Positive urine drug screen or alcohol test at screening.&#xD;
&#xD;
         13. Female subject with positive pregnancy test at screening.&#xD;
&#xD;
         14. Breast-feeding or pregnant subject within 6 months prior to study drug administration.&#xD;
&#xD;
         15. Use of any drugs known as strong inducer or inhibitor of hepatic drug metabolism&#xD;
             within 30 days prior to study drug administration.&#xD;
&#xD;
         16. Use of medication other than stable medications approved by the PI and topical&#xD;
             products without significant systemic absorption.&#xD;
&#xD;
         17. Use of prohibited medications as directed in the protocol.&#xD;
&#xD;
         18. Donation of plasma within 7 days prior to dosing. Donation or loss of blood within 30&#xD;
             days prior to the first dosing.&#xD;
&#xD;
         19. Any reason which, in the opinion of the PI, would prevent the subject from&#xD;
             participating in the study.&#xD;
&#xD;
         20. Inability to be venipunctured and/or tolerate catheter venous access.&#xD;
&#xD;
         21. Presence of mitochondrial mutation(s) making the subject susceptible to aminoglycoside&#xD;
             toxicity.&#xD;
&#xD;
         22. Presence of signs of dehydration, recent history of neuromuscular blockade or&#xD;
             clinically significant history of vestibular impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Inventiv Health Clinical -Research Pharmacy Unit</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.eloxxpharma.com</url>
    <description>Description Eloxx Pharmaceuticals Website</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <results_first_submitted>November 5, 2020</results_first_submitted>
  <results_first_submitted_qc>March 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 13, 2021</results_first_posted>
  <last_update_submitted>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Impaired Renal Function</keyword>
  <keyword>PK</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_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>November 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03776539/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>May 30, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03776539/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All subjects were treated at medical clinics. Groups 1-2 Screening start: January 4, 2019 Screening end: 8 April 2019 Group 3 Screening start: 9 May 2019 Screening end: 17 June 2019 Group 4 Screening start: 26 June 2019 Screening end: 30 June 2019</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Mild Renal Impairment</title>
          <description>eGFR 60 to 89 mL/min/1.73 m^2</description>
        </group>
        <group group_id="P2">
          <title>Moderate Renal Impairment</title>
          <description>eGFR 30 to 59 mL/min/1.73 m^2</description>
        </group>
        <group group_id="P3">
          <title>Severe Renal Impairment</title>
          <description>eGFR &lt;30 mL/min/1.73 m^2, Not Requiring Dialysis</description>
        </group>
        <group group_id="P4">
          <title>Healthy Volunteers</title>
          <description>eGFR &gt;=90 mL/min/1.73 m^2</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
              </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 group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1</title>
          <description>Mild Renal Impairment eGFR 60 to 89 mL/min/1.73 m^2</description>
        </group>
        <group group_id="B2">
          <title>Group 2</title>
          <description>Moderate Renal Impairment eGFR 30 to 59 mL/min/1.73 m^2</description>
        </group>
        <group group_id="B3">
          <title>Group 3</title>
          <description>Severe Renal Impairment eGFR &lt;30 mL/min/1.73 m^2, Not Requiring Dialysis</description>
        </group>
        <group group_id="B4">
          <title>Group 4</title>
          <description>Healthy Volunteers eGFR &gt;=90 mL/min/1.73 m^2</description>
        </group>
        <group group_id="B5">
          <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="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="24"/>
          </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="66.8" spread="5.9"/>
                    <measurement group_id="B2" value="65.0" spread="10.4"/>
                    <measurement group_id="B3" value="61.8" spread="8.2"/>
                    <measurement group_id="B4" value="57.7" spread="2.1"/>
                    <measurement group_id="B5" value="62.8" spread="7.7"/>
                  </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="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="16"/>
                  </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="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </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 group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>eGFR</title>
          <units>mL/min/1.73 m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.72" spread="9.25"/>
                    <measurement group_id="B2" value="40.07" spread="4.54"/>
                    <measurement group_id="B3" value="16.92" spread="9.77"/>
                    <measurement group_id="B4" value="100.25" spread="15.65"/>
                    <measurement group_id="B5" value="57.99" spread="34.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Parameters- Plasma AUC0-24</title>
        <description>Area under the curve (AUC0-24) of ELX-02 plasma concentration following a single subcutaneous (SC) dose</description>
        <time_frame>0.25, 0.5, 0.75, 1, 2, 4, 6, 12, and 24 hours after dosing</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mild Renal Impairment</title>
            <description>eGFR 60 to 89 mL/min/1.73 m^2</description>
          </group>
          <group group_id="O2">
            <title>Moderate Renal Impairment</title>
            <description>eGFR 30 to 59 mL/min/1.73 m^2</description>
          </group>
          <group group_id="O3">
            <title>Severe Renal Impairment</title>
            <description>eGFR &lt;30 mL/min/1.73 m^2, Not Requiring Dialysis</description>
          </group>
          <group group_id="O4">
            <title>Healthy Volunteers</title>
            <description>eGFR &gt;=90 mL/min/1.73 m^2</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameters- Plasma AUC0-24</title>
          <description>Area under the curve (AUC0-24) of ELX-02 plasma concentration following a single subcutaneous (SC) dose</description>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16877.94" spread="1714.57"/>
                    <measurement group_id="O2" value="32787.41" spread="7410.46"/>
                    <measurement group_id="O3" value="64895.29" spread="16967.68"/>
                    <measurement group_id="O4" value="15506.68" spread="3444.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Parameters- Plasma Cmax</title>
        <description>Peak Plasma Concentration (Cmax) of ELX-02 following a single subcutaneous (SC) dose in subjects with normal renal function, mild, moderate, or severe renal impairment</description>
        <time_frame>0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 36, 48, 72, and 168 (Day 8) hours after dosing</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mild Renal Impairment</title>
            <description>eGFR 60 to 89 mL/min/1.73 m^2</description>
          </group>
          <group group_id="O2">
            <title>Moderate Renal Impairment</title>
            <description>eGFR 30 to 59 mL/min/1.73 m^2</description>
          </group>
          <group group_id="O3">
            <title>Severe Renal Impairment</title>
            <description>eGFR &lt;30 mL/min/1.73 m^2, Not Requiring Dialysis</description>
          </group>
          <group group_id="O4">
            <title>Healthy Volunteers</title>
            <description>eGFR &gt;=90 mL/min/1.73 m^2</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameters- Plasma Cmax</title>
          <description>Peak Plasma Concentration (Cmax) of ELX-02 following a single subcutaneous (SC) dose in subjects with normal renal function, mild, moderate, or severe renal impairment</description>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2993.33" spread="280.33"/>
                    <measurement group_id="O2" value="3688.33" spread="525.56"/>
                    <measurement group_id="O3" value="4273.33" spread="947.49"/>
                    <measurement group_id="O4" value="2995.00" spread="568.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-inf</title>
        <description>Area under the curve (AUC0-inf) of ELX-02 plasma concentration following a single subcutaneous (SC) dose</description>
        <time_frame>0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 36, 48, 72, and 168 (Day 8) hours after dosing</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mild Renal Impairment</title>
            <description>eGFR 60 to 89 mL/min/1.73 m^2</description>
          </group>
          <group group_id="O2">
            <title>Moderate Renal Impairment</title>
            <description>eGFR 30 to 59 mL/min/1.73 m^2</description>
          </group>
          <group group_id="O3">
            <title>Severe Renal Impairment</title>
            <description>eGFR &lt;30 mL/min/1.73 m^2, Not Requiring Dialysis</description>
          </group>
          <group group_id="O4">
            <title>Healthy Volunteers</title>
            <description>eGFR &gt;=90 mL/min/1.73 m^2</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-inf</title>
          <description>Area under the curve (AUC0-inf) of ELX-02 plasma concentration following a single subcutaneous (SC) dose</description>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16997.41" spread="1776.84"/>
                    <measurement group_id="O2" value="35179.57" spread="9198.37"/>
                    <measurement group_id="O3" value="110925.53" spread="49098.37"/>
                    <measurement group_id="O4" value="15214.30" spread="2913.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Parameters - Plasma Tmax</title>
        <description>Time to maximum concentration (Tmax) of ELX-02 plasma concentration following a single subcutaneous (SC) dose</description>
        <time_frame>0.25, 0.5, 0.75, 1, 2, 4, 6, 12, and 24 hours after dosing.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mild Renal Impairment</title>
            <description>eGFR 60 to 89 mL/min/1.73 m^2</description>
          </group>
          <group group_id="O2">
            <title>Moderate Renal Impairment</title>
            <description>eGFR 30 to 59 mL/min/1.73 m^2</description>
          </group>
          <group group_id="O3">
            <title>Severe Renal Impairment</title>
            <description>eGFR &lt;30 mL/min/1.73 m^2, Not Requiring Dialysis</description>
          </group>
          <group group_id="O4">
            <title>Healthy Volunteers</title>
            <description>eGFR &gt;=90 mL/min/1.73 m^2</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameters - Plasma Tmax</title>
          <description>Time to maximum concentration (Tmax) of ELX-02 plasma concentration following a single subcutaneous (SC) dose</description>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="0.75" upper_limit="2.00"/>
                    <measurement group_id="O2" value="1.00" lower_limit="0.75" upper_limit="2.00"/>
                    <measurement group_id="O3" value="2.00" lower_limit="1.00" upper_limit="6.00"/>
                    <measurement group_id="O4" value="1.50" lower_limit="0.73" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Urine Pharmacokinetics Parameter - Ae0-t</title>
        <description>Cumulative amount of unchanged drug excreted into urine (Ae0-t) of ELX-02 following a single subcutaneous (SC) dose</description>
        <time_frame>Pre-dose (first void in the morning of Day 1), 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36, 36-48, and 48-72 hours post-dose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mild Renal Impairment</title>
            <description>eGFR 60 to 89 mL/min/1.73 m^2</description>
          </group>
          <group group_id="O2">
            <title>Moderate Renal Impairment</title>
            <description>eGFR 30 to 59 mL/min/1.73 m^2</description>
          </group>
          <group group_id="O3">
            <title>Severe Renal Impairment</title>
            <description>eGFR &lt;30 mL/min/1.73 m^2, Not Requiring Dialysis</description>
          </group>
          <group group_id="O4">
            <title>Healthy Volunteers</title>
            <description>eGFR &gt;=90 mL/min/1.73 m^2</description>
          </group>
        </group_list>
        <measure>
          <title>Urine Pharmacokinetics Parameter - Ae0-t</title>
          <description>Cumulative amount of unchanged drug excreted into urine (Ae0-t) of ELX-02 following a single subcutaneous (SC) dose</description>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.50" spread="19.37"/>
                    <measurement group_id="O2" value="72.10" spread="26.45"/>
                    <measurement group_id="O3" value="54.86" spread="8.74"/>
                    <measurement group_id="O4" value="69.22" spread="17.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Urine Pharmacokinetic Parameter - Rmax</title>
        <description>Maximum rate of urinary extraction (Rmax) of ELX-02 following a single subcutaneous (SC) dose</description>
        <time_frame>Pre-dose (first void in the morning of Day 1), 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36, 36-48, and 48-72 hours post-dose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mild Renal Impairment</title>
            <description>eGFR 60 to 89 mL/min/1.73 m^2</description>
          </group>
          <group group_id="O2">
            <title>Moderate Renal Impairment</title>
            <description>eGFR 30 to 59 mL/min/1.73 m^2</description>
          </group>
          <group group_id="O3">
            <title>Severe Renal Impairment</title>
            <description>eGFR &lt;30 mL/min/1.73 m^2, Not Requiring Dialysis</description>
          </group>
          <group group_id="O4">
            <title>Healthy Volunteers</title>
            <description>eGFR &gt;=90 mL/min/1.73 m^2</description>
          </group>
        </group_list>
        <measure>
          <title>Urine Pharmacokinetic Parameter - Rmax</title>
          <description>Maximum rate of urinary extraction (Rmax) of ELX-02 following a single subcutaneous (SC) dose</description>
          <units>mg/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.18" spread="2.91"/>
                    <measurement group_id="O2" value="8.06" spread="5.91"/>
                    <measurement group_id="O3" value="3.11" spread="1.81"/>
                    <measurement group_id="O4" value="12.09" spread="2.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients Reporting Treatment-Emergent Adverse Events (TEAEs) [Safety]</title>
        <description>TEAEs are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the study treatment</description>
        <time_frame>1-8 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mild Renal Impairment</title>
            <description>eGFR 60 to 89 mL/min/1.73 m^2</description>
          </group>
          <group group_id="O2">
            <title>Moderate Renal Impairment</title>
            <description>eGFR 30 to 59 mL/min/1.73 m^2</description>
          </group>
          <group group_id="O3">
            <title>Severe Renal Impairment</title>
            <description>eGFR &lt;30 mL/min/1.73 m^2, Not Requiring Dialysis</description>
          </group>
          <group group_id="O4">
            <title>Healthy Volunteers</title>
            <description>eGFR &gt;=90 mL/min/1.73 m^2</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Reporting Treatment-Emergent Adverse Events (TEAEs) [Safety]</title>
          <description>TEAEs are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the study treatment</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the date of the signing of the consent form until follow-up visit on Day 8.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Group 1</title>
          <description>Mild Renal Impairment eGFR 60 to 89 mL/min/1.73 m^2</description>
        </group>
        <group group_id="E2">
          <title>Group 2</title>
          <description>Moderate Renal Impairment eGFR 30 to 59 mL/min/1.73 m^2</description>
        </group>
        <group group_id="E3">
          <title>Group 3</title>
          <description>Severe Renal Impairment eGFR &lt;30 mL/min/1.73 m^2, Not Requiring Dialysis</description>
        </group>
        <group group_id="E4">
          <title>Group 4</title>
          <description>Healthy Volunteers eGFR &gt;=90 mL/min/1.73 m^2</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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 21.1">Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 21.1">Injection site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure decrease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Executive Director Clinical Trials</name_or_title>
      <organization>Eloxx Pharmaceuticals</organization>
      <phone>1-781-577-5300</phone>
      <email>CTI@eloxxpharma.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/NCT03776539
org study id: EL-008
nct id: NCT03776539
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Phase 1 - Pharmacokinetics in Patients with Impaired Renal Function
The study is a two-center, Phase 1, open-label, single-dose, one-period, four-parallel-group,
      PK study in subjects with various severities of renal dysfunction and healthy volunteers.

      Subjects will be categorized in 4 groups:

      Group 1: subjects with mild renal impairment Group 2: subjects with moderate renal impairment
      Group 3: subjects with severe renal impairment Group 4 (control group): subjects with normal
      renal function

      The mild (group 1) and moderate (group 2) patients with renal disease will be dosed first, in
      a parallel fashion. At this point, interim PK analyses will be performed and a safety
      committee composed of Sponsor and Contract Research Organization (CRO) members will jointly
      review the PK data before dosing the patients with severe renal disease (group 3). Control
      subjects (group 4) will be recruited after the recruitment of groups 1 to 3.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects will be categorized in 4 groups:
Group 1: subjects with mild renal impairment
Group 2: subjects with moderate renal impairment
Group 3: subjects with severe renal impairment
Group 4 (control group): subjects with normal renal function
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetic Parameters- Plasma AUC0-24
time frame: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, and 24 hours after dosing
description: Area under the curve (AUC0-24) of ELX-02 plasma concentration following a single subcutaneous (SC) dose
measure: Pharmacokinetic Parameters- Plasma Cmax
time frame: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 36, 48, 72, and 168 (Day 8) hours after dosing
description: Peak Plasma Concentration (Cmax) of ELX-02 following a single subcutaneous (SC) dose in subjects with normal renal function, mild, moderate, or severe renal impairment
measure: AUC0-inf
time frame: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 36, 48, 72, and 168 (Day 8) hours after dosing
description: Area under the curve (AUC0-inf) of ELX-02 plasma concentration following a single subcutaneous (SC) dose
measure: Pharmacokinetic Parameters - Plasma Tmax
time frame: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, and 24 hours after dosing.
description: Time to maximum concentration (Tmax) of ELX-02 plasma concentration following a single subcutaneous (SC) dose
measure: Urine Pharmacokinetics Parameter - Ae0-t
time frame: Pre-dose (first void in the morning of Day 1), 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36, 36-48, and 48-72 hours post-dose
description: Cumulative amount of unchanged drug excreted into urine (Ae0-t) of ELX-02 following a single subcutaneous (SC) dose
measure: Urine Pharmacokinetic Parameter - Rmax
time frame: Pre-dose (first void in the morning of Day 1), 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36, 36-48, and 48-72 hours post-dose
description: Maximum rate of urinary extraction (Rmax) of ELX-02 following a single subcutaneous (SC) dose
measure: Number of Patients Reporting Treatment-Emergent Adverse Events (TEAEs) [Safety]
time frame: 1-8 days
description: TEAEs are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the study treatment
arm group label: ELX-02
arm group type: Experimental
description: Drug: ELX-02
intervention type: Drug
intervention name: ELX-02
description: ELX-02 is a synthetic, designer eukaryotic ribosomal specific glycoside (ERSG) optimized as a translational read-through drug. All groups will get the same treatment.
arm group label: ELX-02
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
url: http://www.eloxxpharma.com
description: Description Eloxx Pharmaceuticals Website
responsible party type: Sponsor
mesh term: Renal Insufficiency
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 