<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/NCT02975388</url>
  </required_header>
  <id_info>
    <org_study_id>NP39380</org_study_id>
    <nct_id>NCT02975388</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901</brief_title>
  <official_title>A Multi-Center, Open-Label, Two-Part Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics of RO7079901</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This is a multi-center, non-randomized, open-label, two-part study to investigate the effect&#xD;
      of renal function and hemodialysis on PK of RO7079901. Part 1 will be conducted in adult male&#xD;
      and female participants with stable mild, moderate or severe renal impairment and a control&#xD;
      group of participants with normal renal function. Part 2 will be conducted in adult male and&#xD;
      female participants with stable end-stage renal disease undergoing hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2016</start_date>
  <completion_date type="Actual">July 6, 2017</completion_date>
  <primary_completion_date type="Actual">July 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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Body Clearance (CL) of RO7079901 Using Plasma Concentration Data</measure>
    <time_frame>Blood: Part 1 - Predose (-1 to 0 hour [hr]), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of Distribution of the Central Compartment (Vc) of RO7079901 Using Plasma Concentration Data</measure>
    <time_frame>Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Volume of Distribution (Vz) of RO7079901 Using Plasma Concentration Data</measure>
    <time_frame>Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of Distribution at Steady-State (Vss) of RO7079901 Using Plasma Concentration Data</measure>
    <time_frame>Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal Clearance (CLr) of RO7079901</measure>
    <time_frame>Urine: Part 1 - 0-4, 4-8, 8-12, 12-24 hr postdose; Part 2 - 0-12 hr postdose ( infusion length: 0.5 hr)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Dialysis Clearance (CLd) of RO7079901</measure>
    <time_frame>Dialyzer input, output blood and dialyzer fluid: 1.5 hours postdose (start of hemodialysis); 2.5, 3.5, 4.5 hours postdose (end of hemodialysis) (infusion length: 0.5 hr)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measured Creatinine Clearance (mCLcr)</measure>
    <time_frame>Blood and Urine: Day -1 ( over the 24-hr period predose corresponding to time of micturition), Day 1 ( Part 1)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimated Creatinine Clearance Using the Cockcroft and Gault Formula (eCLcr[CG])</measure>
    <time_frame>Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimated Creatinine Clearance Using the Modified Jelliffe Formula (eCLcr[Jelliffe])</measure>
    <time_frame>Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimated Glomerular Filtration Rate (eGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula (eGFR[MDRD])</measure>
    <time_frame>Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>eGFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Formula (eGFR[CKD-EPI])</measure>
    <time_frame>Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time 0 to infinity (AUC0-inf) of RO7079901</measure>
    <time_frame>Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of RO7079901</measure>
    <time_frame>Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Cmax (tmax) of RO7079901</measure>
    <time_frame>Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Elimination Half-life (t1/2) of RO7079901</measure>
    <time_frame>Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Amount Excreted in Urine (Ae) of RO7079901</measure>
    <time_frame>Urine: Part 1 - 0-4, 4-8, 8-12, 12-24 hr postdose; Part 2 - 0-12 hr postdose (infusion length: 0.5 hr)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction Excreted in Urine (Fe) of RO7079901</measure>
    <time_frame>Blood:Predose (-1 to 0hr), 0.5, 1, 1.5, 8, 12, 24 hr postdose(Parts 1 and 2); 2, 3, 4, 6 hr postdose(Part 1); 4.5 hr postdose(end of hemodialysis)(Part 2); Urine:0-4, 4-8, 8-12, 12-24 hr postdose(Part 1); 0-12 hr postdose(Part 2)(infusion length: 0.5 hr)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Adverse Events (AEs)</measure>
    <time_frame>Baseline up to end of the study (up to approximately 7 months)</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Renal Impairment</condition>
  <arm_group>
    <arm_group_label>Label: RO7079901 (Mild) (Part 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with mild renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RO7079901 (Moderate) (Part 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with moderate renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RO7079901 (Severe) (Part 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with severe renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RO7079901 (Normal) (Part 1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group of participants with normal renal function will be enrolled in this arm. Participants will receive the specified dose of RO7079901.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RO7079901 (End-stage) (Part 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with stable end-stage renal disease undergoing hemodialysis will be enrolled in this arm. Participants will receive the specified dose of RO7079901.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO7079901</intervention_name>
    <description>Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.</description>
    <arm_group_label>Label: RO7079901 (Mild) (Part 1)</arm_group_label>
    <arm_group_label>RO7079901 (End-stage) (Part 2)</arm_group_label>
    <arm_group_label>RO7079901 (Moderate) (Part 1)</arm_group_label>
    <arm_group_label>RO7079901 (Normal) (Part 1)</arm_group_label>
    <arm_group_label>RO7079901 (Severe) (Part 1)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Body Mass Index (BMI) between 18 and 38 kilograms per square-meter (kg/m^2) and body&#xD;
        weight of at least 45 kilograms (kg)&#xD;
&#xD;
        Control group participants, Part 1 only:&#xD;
&#xD;
          -  Normal renal function based on creatinine clearance greater than or equal to (&gt;=) 90&#xD;
             milliliters per minute (mL/min) at the Screening visit&#xD;
&#xD;
          -  Healthy for age-group, as determined by the investigator on the basis of medical&#xD;
             history, physical examination, clinical laboratory test results, vital signs, and&#xD;
             12-lead electrocardiogram (ECG)&#xD;
&#xD;
        Participants with renal impairment, Part 1 only:&#xD;
&#xD;
          -  Reduced renal function based on estimated creatinine clearance at the Screening visit.&#xD;
             Creatinine clearance can be estimated from serum creatinine concentration at the&#xD;
             Screening visit using the Cockcroft-Gault equation, or be a historical measured value&#xD;
             obtained within the preceding 3 months. Participants with severe, moderate or mild&#xD;
             renal impairment must have creatinine clearance of less than or equal to (&lt;=) 29, 30&#xD;
             to 59, or 60 to 89 mL/min, respectively&#xD;
&#xD;
          -  Stable renal function. The stability of renal function will be confirmed by two&#xD;
             determinations of serum creatinine separated by at least 7 days (one of which can be a&#xD;
             historical value within the last 3 months). Renal function will be considered stable&#xD;
             if the 2 serum creatinine values differ by &lt;=30 percent (%) of the lower value&#xD;
&#xD;
        Participants with end-stage renal disease in Part 2 only:&#xD;
&#xD;
          -  Reduced renal function with a clinical diagnosis of end-stage renal disease requiring&#xD;
             renal replacement therapy&#xD;
&#xD;
          -  Receiving hemodialysis for more than 3 months at the time of the Screening visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recipient of a renal transplant (Part 1 only)&#xD;
&#xD;
          -  Presence of renal carcinoma, or acute renal disease caused by infection or drug&#xD;
             toxicity&#xD;
&#xD;
          -  Nephrotic syndrome (defined as plasma albumin less than [&lt;] 3 grams per deciliter&#xD;
             [g/dL] and/or proteinuria greater than [&gt;] 3 grams per day [g/day])&#xD;
&#xD;
          -  Hemoglobin concentration &lt;10 g/dL, or &lt;9 g/dL for participants with end-stage renal&#xD;
             disease&#xD;
&#xD;
          -  Potassium concentration &gt;5.5 millimoles per liter (mmol/L)&#xD;
&#xD;
          -  Clinically significant liver disease&#xD;
&#xD;
          -  Uncontrolled blood pressure&#xD;
&#xD;
          -  Any condition associated with intra-vascular volume depletion&#xD;
&#xD;
          -  Any unstable clinically significant disease&#xD;
&#xD;
          -  Any other ongoing condition or disease (apart from renal dysfunction), or clinically&#xD;
             significant abnormalities in laboratory test results that the investigator considers&#xD;
             would render the participant unsuitable for the study, place the participant at undue&#xD;
             risk or interfere with the ability of the participant to complete the study&#xD;
&#xD;
          -  Major surgery or significant traumatic injury &lt;28 days prior to the first&#xD;
             administration (excluding biopsies), or anticipation of the need for major surgery&#xD;
             during study treatment&#xD;
&#xD;
          -  Recent history of alcoholism, drug abuse, or addiction within the last year prior to&#xD;
             screening&#xD;
&#xD;
          -  Positive test at Screening of any of the following: Hepatitis A, Hepatitis B,&#xD;
             Hepatitis C, or human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Clinically significant change in disease status as judged by the investigator, or any&#xD;
             major illness within the 4 weeks prior to the Screening visit, or febrile illness&#xD;
             within 14 days prior to the Screening visit&#xD;
&#xD;
          -  Use of prohibited medications, or alteration to a concomitant medication treatment&#xD;
             regimen considered relevant by the investigator within 14 days before the Screening&#xD;
             visit&#xD;
&#xD;
          -  Known history of clinically significant hypersensitivity or severe allergic reaction&#xD;
             to any drug, in particular antibiotics (e.g., cephalosporins, penicillins,&#xD;
             carbapenems, or monobactams)&#xD;
&#xD;
          -  Participation in another clinical study with an investigational drug or device within&#xD;
             the 1 month preceding the Screening vist&#xD;
&#xD;
          -  Donation or loss of over 500 milliliters (mL) of blood within the 3 months before the&#xD;
             Screening visit&#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>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-LaRoche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Pharmacology of Miami, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Clinical Research Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Clinical Research</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prism Clinical Research</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Orleans Center for Clinical Research</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>December 7, 2017</last_update_submitted>
  <last_update_submitted_qc>December 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2017</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>Renal Insufficiency</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02975388
org study id: NP39380
nct id: NCT02975388
lead sponsor: 
This is a multi-center, non-randomized, open-label, two-part study to investigate the effect
      of renal function and hemodialysis on PK of RO7079901. Part 1 will be conducted in adult male
      and female participants with stable mild, moderate or severe renal impairment and a control
      group of participants with normal renal function. Part 2 will be conducted in adult male and
      female participants with stable end-stage renal disease undergoing hemodialysis.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total Body Clearance (CL) of RO7079901 Using Plasma Concentration Data
time frame: Blood: Part 1 - Predose (-1 to 0 hour [hr]), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)
measure: Volume of Distribution of the Central Compartment (Vc) of RO7079901 Using Plasma Concentration Data
time frame: Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)
measure: Total Volume of Distribution (Vz) of RO7079901 Using Plasma Concentration Data
time frame: Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)
measure: Volume of Distribution at Steady-State (Vss) of RO7079901 Using Plasma Concentration Data
time frame: Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)
measure: Renal Clearance (CLr) of RO7079901
time frame: Urine: Part 1 - 0-4, 4-8, 8-12, 12-24 hr postdose; Part 2 - 0-12 hr postdose ( infusion length: 0.5 hr)
measure: Part 2: Dialysis Clearance (CLd) of RO7079901
time frame: Dialyzer input, output blood and dialyzer fluid: 1.5 hours postdose (start of hemodialysis); 2.5, 3.5, 4.5 hours postdose (end of hemodialysis) (infusion length: 0.5 hr)
measure: Measured Creatinine Clearance (mCLcr)
time frame: Blood and Urine: Day -1 ( over the 24-hr period predose corresponding to time of micturition), Day 1 ( Part 1)
measure: Estimated Creatinine Clearance Using the Cockcroft and Gault Formula (eCLcr[CG])
time frame: Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)
measure: Estimated Creatinine Clearance Using the Modified Jelliffe Formula (eCLcr[Jelliffe])
time frame: Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)
measure: Estimated Glomerular Filtration Rate (eGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula (eGFR[MDRD])
time frame: Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)
measure: eGFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Formula (eGFR[CKD-EPI])
time frame: Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)
measure: Area Under the Plasma Concentration-Time Curve From Time 0 to infinity (AUC0-inf) of RO7079901
time frame: Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)
measure: Maximum Plasma Concentration (Cmax) of RO7079901
time frame: Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)
measure: Time to Reach Cmax (tmax) of RO7079901
time frame: Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)
measure: Terminal Elimination Half-life (t1/2) of RO7079901
time frame: Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)
measure: Cumulative Amount Excreted in Urine (Ae) of RO7079901
time frame: Urine: Part 1 - 0-4, 4-8, 8-12, 12-24 hr postdose; Part 2 - 0-12 hr postdose (infusion length: 0.5 hr)
measure: Fraction Excreted in Urine (Fe) of RO7079901
time frame: Blood:Predose (-1 to 0hr), 0.5, 1, 1.5, 8, 12, 24 hr postdose(Parts 1 and 2); 2, 3, 4, 6 hr postdose(Part 1); 4.5 hr postdose(end of hemodialysis)(Part 2); Urine:0-4, 4-8, 8-12, 12-24 hr postdose(Part 1); 0-12 hr postdose(Part 2)(infusion length: 0.5 hr)
measure: Percentage of Participants with Adverse Events (AEs)
time frame: Baseline up to end of the study (up to approximately 7 months)
arm group label: Label: RO7079901 (Mild) (Part 1)
arm group type: Experimental
description: Participants with mild renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
arm group label: RO7079901 (Moderate) (Part 1)
arm group type: Experimental
description: Participants with moderate renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
arm group label: RO7079901 (Severe) (Part 1)
arm group type: Experimental
description: Participants with severe renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
arm group label: RO7079901 (Normal) (Part 1)
arm group type: Active Comparator
description: Control group of participants with normal renal function will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
arm group label: RO7079901 (End-stage) (Part 2)
arm group type: Experimental
description: Participants with stable end-stage renal disease undergoing hemodialysis will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
intervention type: Drug
intervention name: RO7079901
description: Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.
arm group label: Label: RO7079901 (Mild) (Part 1)
arm group label: RO7079901 (End-stage) (Part 2)
arm group label: RO7079901 (Moderate) (Part 1)
arm group label: RO7079901 (Normal) (Part 1)
arm group label: RO7079901 (Severe) (Part 1)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-LaRoche
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Renal Insufficiency