<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/NCT02972255</url>
  </required_header>
  <id_info>
    <org_study_id>NP30052</org_study_id>
    <nct_id>NCT02972255</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7079901 and the Combination of RO7079901 With Meropenem in Adult Healthy Volunteers</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of RO7079901 Administered Intravenously Both Alone and in Combination With Meropenem in Adult Healthy Volunteers</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 randomized, double-blind, placebo-controlled, multiple-ascending dose (MAD) study&#xD;
      that will evaluate the safety, tolerability and pharmacokinetics (PK) of RO7079901 and the&#xD;
      combination of RO7079901 with meropenem in healthy volunteers. The study will consist of&#xD;
      three parts (Part I, II, and III). At each dose level/cohort, a total of 8 healthy volunteers&#xD;
      will be randomized to receive active study drug or placebo in a 3:1 ratio.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2016</start_date>
  <completion_date type="Actual">March 24, 2017</completion_date>
  <primary_completion_date type="Actual">March 24, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part I: Percentage of Participants With Adverse Events</measure>
    <time_frame>From screening to the follow-up or early withdrawal visit (up to Day 15)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II: Percentage of Participants With Adverse Events</measure>
    <time_frame>From screening to the follow-up or early withdrawal visit (up to Day 17)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Percentage of Participants With Adverse Events</measure>
    <time_frame>From screening to the follow-up or early withdrawal visit (up to Day 17)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Maximum Observed Plasma Concentration (Cmax) of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hour [hr]) (infusion duration: 90 minutes [min]), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Time to Reach Cmax (Tmax) of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Area Under the Plasma Concentration-Time Curve From Time Zero Until End of Dosing Interval (AUC0-tau) of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Terminal Elimination Rate Constant of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Terminal Elimination Half-Life (t1/2) of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Total Clearance (CL) of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Volume of Distribution at Steady State (Vss) of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Cmax of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Tmax of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: AUC0-tau of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Terminal Elimination Rate Constant of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: t1/2 of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Cmax of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Tmax of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: AUC0-tau of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Terminal Elimination Rate Constant of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: t1/2 of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Cmax of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Tmax of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: AUC0-tau of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Terminal Elimination Rate Constant of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: t1/2 of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: CL of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Vss of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Cmax of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Tmax of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: AUC0-tau of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Terminal Elimination Rate Constant of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: t1/2 of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Cmax of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Tmax of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: AUC0-tau of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Terminal Elimination Rate Constant of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: t1/2 of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Cmax of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Tmax of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: AUC0-tau of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Terminal Elimination Rate Constant of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: t1/2 of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: CL of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Vss of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Cmax of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Tmax of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: AUC0-tau of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Terminal Elimination Rate Constant of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: t1/2 of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Cmax of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Tmax of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: AUC0-tau of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Terminal Elimination Rate Constant of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: t1/2 of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Cumulative Amount of RO7079901 Excreted in Urine (Ae)</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Ae From Time 0 to End of the Dosing Interval (8 hrs) (Ae0-tau) of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Percent of RO7079901 Dose Excreted in Urine (Ae%), Calculated as Ae0-tau/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Renal Clearance (CLr) of RO7079901, Calculated as Ae0-tau/AUC0-tau</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Ae of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Ae0-tau of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Ae% of Metabolite RO7110880, Calculated as Ae0-tau/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: CLr of Metabolite RO7110880, Calculated as Ae0-tau/AUC0-tau</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Ae of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Ae0-tau of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Ae% of Metabolite RO7053802, Calculated as Ae0-tau/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: CLr of Metabolite RO7053802, Calculated as Ae0-tau/AUC0-tau</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Ae of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Ae0-tau of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Ae% of RO7079901, Calculated as Ae0-tau/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: CLr of RO7079901, Calculated as Ae0-tau/AUC0-tau</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Ae of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Ae0-tau of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Ae% of Metabolite RO7110880, Calculated as Ae0-tau/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: CLr of Metabolite RO7110880, Calculated as Ae0-tau/AUC0-tau</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Ae of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Ae0-tau of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Ae% of Metabolite RO7053802, Calculated as Ae0-tau/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: CLr of Metabolite RO7053802, Calculated as Ae0-tau/AUC0-tau</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Ae of RO7079901</measure>
    <time_frame>Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Ae0-tau of RO7079901</measure>
    <time_frame>Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Ae% of RO7079901, Calculated as Ae0-tau/Dose</measure>
    <time_frame>Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: CLr of RO7079901, Calculated as Ae0-tau/AUC0-tau</measure>
    <time_frame>Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Ae of Metabolite RO7110880</measure>
    <time_frame>Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Ae0-tau of Metabolite RO7110880</measure>
    <time_frame>Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Ae% of Metabolite RO7110880, Calculated as Ae0-tau/Dose</measure>
    <time_frame>Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: CLr of Metabolite RO7110880, Calculated as Ae0-tau/AUC0-tau</measure>
    <time_frame>Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Ae of Metabolite RO7053802</measure>
    <time_frame>Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Ae0-tau of Metabolite RO7053802</measure>
    <time_frame>Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: Ae% of Metabolite RO7053802, Calculated as Ae0-tau/Dose</measure>
    <time_frame>Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: CLr of Metabolite RO7053802, Calculated as Ae0-tau/AUC0-tau</measure>
    <time_frame>Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24h) of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: AUC0-last of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: AUC0-24h of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: AUC0-inf of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: AUC0-last of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: AUC0-24h of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Single Dose: AUC0-inf of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: AUC0-last of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: AUC0-24h of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: AUC0-inf of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: AUC0-last of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: AUC0-24h of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: AUC0-inf of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: AUC0-last of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: AUC0-24h of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II - Repeat Dose: AUC0-inf of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II: Cumulative Amount of RO7079901 Excreted in Urine From Time 0 to 24 Hours (Ae0-24h)</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II: Ae% of RO7079901, Calculated as Ae0-24h/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II: CLr of RO7079901, Calculated as Ae0-24h/AUC0-24h</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II: Ae0-24 of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II: Ae% of Metabolite RO7110880, Calculated as Ae0-24h/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II: CLr of Metabolite RO7110880, Calculated as Ae0-24h/AUC0-24h</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II: Ae0-24 of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II: Ae% of Metabolite RO7053802, Calculated as Ae0-24h/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II: CLr of Metabolite RO7053802, Calculated as Ae0-24h/AUC0-24h</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Cmax of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Tmax of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: AUC0-tau of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: AUC0-last of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: AUC0-inf of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Terminal Elimination Rate Constant of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: t1/2 of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: CL of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Vss of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Cmax of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Tmax of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: AUC0-tau of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: AUC0-last of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: AUC0-inf of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Terminal Elimination Rate Constant of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: t1/2 of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Cmax of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Tmax of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: AUC0-tau of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: AUC0-last of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: AUC0-inf of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Terminal Elimination Rate Constant of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: t1/2 of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae0-tau of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae0-24h of RO7079901</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae% of RO7079901, Calculated as Ae0-tau/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae% of RO7079901, Calculated as Ae0-24h/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: CLr of RO7079901, Calculated as Ae0-tau/AUC0-tau</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: CLr of RO7079901, Calculated as Ae0-24h/AUC0-24h</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae0-tau of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae0-24h of Metabolite RO7110880</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae% of Metabolite RO7110880, Calculated as Ae0-tau/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae% of Metabolite RO7110880, Calculated as Ae0-24h/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: CLr of Metabolite RO7110880, Calculated as Ae0-tau/AUC0-tau</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: CLr of Metabolite RO7110880, Calculated as Ae0-24h/AUC0-24h</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae0-tau of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae0-24h of Metabolite RO7053802</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae% of Metabolite RO7053802, Calculated as Ae0-tau/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: Ae% of Metabolite RO7053802, Calculated as Ae0-24h/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: CLr of Metabolite RO7053802, Calculated as Ae0-tau/AUC0-tau</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III: CLr of Metabolite RO7053802, Calculated as Ae0-24h/AUC0-24h</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part III: Cmax of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Tmax of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: AUC0-tau of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: AUC0-last of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: AUC0-inf of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Terminal Elimination Rate Constant of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: t1/2 of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: CL of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Vss of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Cmax of Open Ring Metabolite of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Tmax of Open Ring Metabolite of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: AUC0-tau of Open Ring Metabolite of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: AUC0-last of Open Ring Metabolite of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: AUC0-inf of Open Ring Metabolite of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Terminal Elimination Rate Constant of Open Ring Metabolite of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: t1/2 of Open Ring Metabolite of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Ae of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Ae0-tau of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Ae0-24h of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Ae% of Meropenem, Calculated as Ae0-tau/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Ae% of Meropenem, Calculated as Ae0-24h/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: CLr of Meropenem, Calculated as Ae0-tau/AUC0-tau</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: CLr of Meropenem, Calculated as Ae0-24h/AUC0-24h</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Ae of Open Ring Metabolite of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Ae0-tau of Open Ring Metabolite of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Ae0-24h of Open Ring Metabolite of Meropenem</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Ae% of Open Ring Metabolite of Meropenem, Calculated as Ae0-tau/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: Ae% of Open Ring Metabolite of Meropenem, Calculated as Ae0-24h/Dose</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: CLr of Open Ring Metabolite of Meropenem, Calculated as Ae0-tau/AUC0-tau</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part III: CLr of Open Ring Metabolite of Meropenem, Calculated as Ae0-24h/AUC0-24h</measure>
    <time_frame>Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Part I: RO7079901</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized in two dose cohorts to receive single dose of RO7079901 1000 and 2000 milligrams (mg) intravenous (IV) infusion on Days 1 through Day 7 every 8 hours (q8h), for a total of 19 doses, with the last dose administered on the morning of Day 7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part I: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be randomized in two dose cohorts to receive single dose of placebo matching to RO7079901 on Days 1 through Day 7 q8h, for a total of 19 doses, with the last dose administered on the morning of Day 7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part II - Single Dose and Repeat Dose: RO7079901</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized in two dose cohorts to receive single dose of RO7079901 IV infusion at a dose above the previously studied dose levels in Part I (greater than [&gt;] 2000 mg) on Day 1, with the option to extend to q8h dosing for 7 days (i.e., starting on Day 3 through Day 9); once PK, safety and tolerability have been confirmed up to 48 hrs after the single dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part II - Single Dose and Repeat Dose: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be randomized in two dose cohorts to receive single dose placebo matching to RO7079901 on Day 1, with the option to extend to q8h dosing for 7 days (i.e., starting on Day 3 through Day 9); once PK, safety and tolerability have been confirmed up to 48 hrs after the single dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part III: RO7079901 + Meropenem</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized in three dose cohorts to receive RO7079901 and Meropenem IV infusion in one of the 2 treatment sequences. Participants randomized to Sequence 1 will receive a single dose of 2000 mg meropenem IV infusion on Day 1. On Day 2, participants will receive a single dose of RO7079901 IV infusion. Participants randomized to Sequence 2 will receive a single dose of RO7079901 IV infusion on Day 1. On Day 2, participants will receive a single dose of 2000 mg meropenem IV infusion. Starting on Day 3 and continuing through Day 9 (i.e., for a total of 19 doses, last dose in the morning of Day 9) all participants will receive RO7079901 in combination with meropenem IV infusion q8h, regardless of sequence. Escalation to a maximum dose of RO7079901 5000 mg q8h may be considered on the basis of safety and tolerability data from the previous cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part III: RO7079901 Placebo + Meropenem Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be randomized in three dose cohorts to receive RO7079901 and Meropenem matching placebos in one of the 2 treatment sequences. Participants randomized to Sequence 1 will receive a single dose of placebo matching to meropenem on Day 1. On Day 2, participants will receive a single dose of placebo matching to RO7079901. Participants randomized to Sequence 2 will receive a single dose of placebo matching to RO7079901 on Day 1. On Day 2, participants will receive a single dose of placebo matching to meropenem. Starting on Day 3 and continuing through Day 9 (i.e., for a total of 19 doses, last dose in the morning of Day 9) all participants will receive RO7079901 and meropenem matching placebos q8h, regardless of sequence.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO7079901</intervention_name>
    <description>RO7079901 will be administered as per schedule described in individual arm.</description>
    <arm_group_label>Part I: RO7079901</arm_group_label>
    <arm_group_label>Part II - Single Dose and Repeat Dose: RO7079901</arm_group_label>
    <arm_group_label>Part III: RO7079901 + Meropenem</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Meropenem</intervention_name>
    <description>Meropenem will be administered as per schedule described in individual arm.</description>
    <arm_group_label>Part III: RO7079901 + Meropenem</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>RO7049389 Placebo</intervention_name>
    <description>Placebo matching to RO7049389 will be administered as per schedule described in individual arm.</description>
    <arm_group_label>Part I: Placebo</arm_group_label>
    <arm_group_label>Part II - Single Dose and Repeat Dose: Placebo</arm_group_label>
    <arm_group_label>Part III: RO7079901 Placebo + Meropenem Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meropenem Placebo</intervention_name>
    <description>Placebo matching to meropenem will be administered as per schedule described in individual arm.</description>
    <arm_group_label>Part III: RO7079901 Placebo + Meropenem Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or healthy female of non-childbearing-potential&#xD;
&#xD;
          -  A Body Mass Index (BMI) between 18.0 and 30.0 kilograms per square meter (kg/m^2)&#xD;
             (inclusive) and a body weight of at least 45 kilograms (kg) at screening&#xD;
&#xD;
          -  Negative urine drug and alcohol screen (barbiturates, benzodiazepines, methadone,&#xD;
             amphetamines, methamphetamines, opiates, cocaine, cannabinoids, cotinine, and alcohol)&#xD;
&#xD;
          -  Non-smokers, or former smokers, who have not smoked for at least 60 days prior to&#xD;
             screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known history of any significant hypersensitivity or severe allergic reaction to any&#xD;
             beta-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems, or&#xD;
             monobactams)&#xD;
&#xD;
          -  History of any severe antibiotic-associated superinfections like Clostridium difficile&#xD;
             colitis and/or frequent fungal vaginal infections&#xD;
&#xD;
          -  Concurrent or history of clinically significant cardiovascular, hepatic, renal,&#xD;
             endocrine, gastrointestinal, respiratory, psychiatric, neurologic, and/or&#xD;
             hematological disorders&#xD;
&#xD;
          -  A history or presence of malignancy (with the exception of successfully treated basal&#xD;
             cell carcinoma); seizures, brain lesions or other significant neurological diseases&#xD;
&#xD;
          -  Donation of blood (or loss of blood) greater than 500 milliliters (mL) within three&#xD;
             months before screening&#xD;
&#xD;
          -  History of Gilbert syndrome&#xD;
&#xD;
          -  Any clinically significant concomitant disease or condition that could interfere with,&#xD;
             or treatment of which might interfere with, the conduct of the study, or that would,&#xD;
             in the opinion of the investigator, pose an unacceptable risk to the healthy volunteer&#xD;
             in this study&#xD;
&#xD;
          -  Positive test at screening of any of the following: Hepatitis A Virus Immunoglobulin M&#xD;
             Antibody (HAV IgM Ab), Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus&#xD;
             Ribonucleic Acid or Hepatitis C Virus Antibody (HCV RNA or HCVAb), or Human&#xD;
             Immunodeficiency Virus Antibody (HIV Ab)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 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-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Unit Inc.; Covance Gfi Research</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Covance Clinical Research Unit, Inc</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>May 18, 2017</last_update_submitted>
  <last_update_submitted_qc>May 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meropenem</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02972255
org study id: NP30052
nct id: NCT02972255
lead sponsor: 
This is a randomized, double-blind, placebo-controlled, multiple-ascending dose (MAD) study
      that will evaluate the safety, tolerability and pharmacokinetics (PK) of RO7079901 and the
      combination of RO7079901 with meropenem in healthy volunteers. The study will consist of
      three parts (Part I, II, and III). At each dose level/cohort, a total of 8 healthy volunteers
      will be randomized to receive active study drug or placebo in a 3:1 ratio.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Part I: Percentage of Participants With Adverse Events
time frame: From screening to the follow-up or early withdrawal visit (up to Day 15)
measure: Part II: Percentage of Participants With Adverse Events
time frame: From screening to the follow-up or early withdrawal visit (up to Day 17)
measure: Part III: Percentage of Participants With Adverse Events
time frame: From screening to the follow-up or early withdrawal visit (up to Day 17)
measure: Part I: Maximum Observed Plasma Concentration (Cmax) of RO7079901
time frame: Pre-infusion (0-1 hour [hr]) (infusion duration: 90 minutes [min]), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: Time to Reach Cmax (Tmax) of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: Area Under the Plasma Concentration-Time Curve From Time Zero Until End of Dosing Interval (AUC0-tau) of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: Terminal Elimination Rate Constant of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: Terminal Elimination Half-Life (t1/2) of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: Total Clearance (CL) of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: Volume of Distribution at Steady State (Vss) of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: Cmax of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: Tmax of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: AUC0-tau of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: Terminal Elimination Rate Constant of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: t1/2 of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: Cmax of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: Tmax of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: AUC0-tau of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: Terminal Elimination Rate Constant of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part I: t1/2 of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
measure: Part II - Single Dose: Cmax of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: Tmax of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: AUC0-tau of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: Terminal Elimination Rate Constant of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: t1/2 of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: CL of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: Vss of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: Cmax of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: Tmax of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: AUC0-tau of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: Terminal Elimination Rate Constant of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: t1/2 of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: Cmax of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: Tmax of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: AUC0-tau of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: Terminal Elimination Rate Constant of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: t1/2 of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Repeat Dose: Cmax of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: Tmax of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: AUC0-tau of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: Terminal Elimination Rate Constant of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: t1/2 of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: CL of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: Vss of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: Cmax of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: Tmax of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: AUC0-tau of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: Terminal Elimination Rate Constant of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: t1/2 of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: Cmax of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: Tmax of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: AUC0-tau of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: Terminal Elimination Rate Constant of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part II - Repeat Dose: t1/2 of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
measure: Part I: Cumulative Amount of RO7079901 Excreted in Urine (Ae)
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
measure: Part I: Ae From Time 0 to End of the Dosing Interval (8 hrs) (Ae0-tau) of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
measure: Part I: Percent of RO7079901 Dose Excreted in Urine (Ae%), Calculated as Ae0-tau/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
measure: Part I: Renal Clearance (CLr) of RO7079901, Calculated as Ae0-tau/AUC0-tau
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
measure: Part I: Ae of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
measure: Part I: Ae0-tau of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
measure: Part I: Ae% of Metabolite RO7110880, Calculated as Ae0-tau/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
measure: Part I: CLr of Metabolite RO7110880, Calculated as Ae0-tau/AUC0-tau
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
measure: Part I: Ae of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
measure: Part I: Ae0-tau of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
measure: Part I: Ae% of Metabolite RO7053802, Calculated as Ae0-tau/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
measure: Part I: CLr of Metabolite RO7053802, Calculated as Ae0-tau/AUC0-tau
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
measure: Part II - Single Dose: Ae of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II - Single Dose: Ae0-tau of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II - Single Dose: Ae% of RO7079901, Calculated as Ae0-tau/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II - Single Dose: CLr of RO7079901, Calculated as Ae0-tau/AUC0-tau
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II - Single Dose: Ae of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II - Single Dose: Ae0-tau of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II - Single Dose: Ae% of Metabolite RO7110880, Calculated as Ae0-tau/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II - Single Dose: CLr of Metabolite RO7110880, Calculated as Ae0-tau/AUC0-tau
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II - Single Dose: Ae of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II - Single Dose: Ae0-tau of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II - Single Dose: Ae% of Metabolite RO7053802, Calculated as Ae0-tau/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II - Single Dose: CLr of Metabolite RO7053802, Calculated as Ae0-tau/AUC0-tau
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II - Repeat Dose: Ae of RO7079901
time frame: Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
measure: Part II - Repeat Dose: Ae0-tau of RO7079901
time frame: Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
measure: Part II - Repeat Dose: Ae% of RO7079901, Calculated as Ae0-tau/Dose
time frame: Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
measure: Part II - Repeat Dose: CLr of RO7079901, Calculated as Ae0-tau/AUC0-tau
time frame: Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
measure: Part II - Repeat Dose: Ae of Metabolite RO7110880
time frame: Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
measure: Part II - Repeat Dose: Ae0-tau of Metabolite RO7110880
time frame: Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
measure: Part II - Repeat Dose: Ae% of Metabolite RO7110880, Calculated as Ae0-tau/Dose
time frame: Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
measure: Part II - Repeat Dose: CLr of Metabolite RO7110880, Calculated as Ae0-tau/AUC0-tau
time frame: Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
measure: Part II - Repeat Dose: Ae of Metabolite RO7053802
time frame: Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
measure: Part II - Repeat Dose: Ae0-tau of Metabolite RO7053802
time frame: Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
measure: Part II - Repeat Dose: Ae% of Metabolite RO7053802, Calculated as Ae0-tau/Dose
time frame: Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
measure: Part II - Repeat Dose: CLr of Metabolite RO7053802, Calculated as Ae0-tau/AUC0-tau
time frame: Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
measure: Part II - Single Dose: Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24h) of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: AUC0-last of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: AUC0-24h of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: AUC0-inf of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: AUC0-last of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: AUC0-24h of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Single Dose: AUC0-inf of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
measure: Part II - Repeat Dose: AUC0-last of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
measure: Part II - Repeat Dose: AUC0-24h of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
measure: Part II - Repeat Dose: AUC0-inf of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
measure: Part II - Repeat Dose: AUC0-last of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
measure: Part II - Repeat Dose: AUC0-24h of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
measure: Part II - Repeat Dose: AUC0-inf of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
measure: Part II - Repeat Dose: AUC0-last of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
measure: Part II - Repeat Dose: AUC0-24h of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
measure: Part II - Repeat Dose: AUC0-inf of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
measure: Part II: Cumulative Amount of RO7079901 Excreted in Urine From Time 0 to 24 Hours (Ae0-24h)
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II: Ae% of RO7079901, Calculated as Ae0-24h/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II: CLr of RO7079901, Calculated as Ae0-24h/AUC0-24h
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II: Ae0-24 of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II: Ae% of Metabolite RO7110880, Calculated as Ae0-24h/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II: CLr of Metabolite RO7110880, Calculated as Ae0-24h/AUC0-24h
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II: Ae0-24 of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II: Ae% of Metabolite RO7053802, Calculated as Ae0-24h/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part II: CLr of Metabolite RO7053802, Calculated as Ae0-24h/AUC0-24h
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
measure: Part III: Cmax of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: Tmax of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: AUC0-tau of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: AUC0-last of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
measure: Part III: AUC0-inf of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
measure: Part III: Terminal Elimination Rate Constant of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: t1/2 of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: CL of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: Vss of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: Cmax of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: Tmax of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: AUC0-tau of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: AUC0-last of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
measure: Part III: AUC0-inf of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
measure: Part III: Terminal Elimination Rate Constant of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: t1/2 of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: Cmax of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: Tmax of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: AUC0-tau of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: AUC0-last of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
measure: Part III: AUC0-inf of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
measure: Part III: Terminal Elimination Rate Constant of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: t1/2 of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: Ae of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae0-tau of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae0-24h of RO7079901
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
measure: Part III: Ae% of RO7079901, Calculated as Ae0-tau/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae% of RO7079901, Calculated as Ae0-24h/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
measure: Part III: CLr of RO7079901, Calculated as Ae0-tau/AUC0-tau
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: CLr of RO7079901, Calculated as Ae0-24h/AUC0-24h
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
measure: Part III: Ae of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae0-tau of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae0-24h of Metabolite RO7110880
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
measure: Part III: Ae% of Metabolite RO7110880, Calculated as Ae0-tau/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae% of Metabolite RO7110880, Calculated as Ae0-24h/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
measure: Part III: CLr of Metabolite RO7110880, Calculated as Ae0-tau/AUC0-tau
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: CLr of Metabolite RO7110880, Calculated as Ae0-24h/AUC0-24h
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
measure: Part III: Ae of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae0-tau of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae0-24h of Metabolite RO7053802
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
measure: Part III: Ae% of Metabolite RO7053802, Calculated as Ae0-tau/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae% of Metabolite RO7053802, Calculated as Ae0-24h/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
measure: Part III: CLr of Metabolite RO7053802, Calculated as Ae0-tau/AUC0-tau
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: CLr of Metabolite RO7053802, Calculated as Ae0-24h/AUC0-24h
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
measure: Part III: Cmax of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: Tmax of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: AUC0-tau of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: AUC0-last of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
measure: Part III: AUC0-inf of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
measure: Part III: Terminal Elimination Rate Constant of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: t1/2 of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: CL of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: Vss of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: Cmax of Open Ring Metabolite of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: Tmax of Open Ring Metabolite of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: AUC0-tau of Open Ring Metabolite of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: AUC0-last of Open Ring Metabolite of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
measure: Part III: AUC0-inf of Open Ring Metabolite of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
measure: Part III: Terminal Elimination Rate Constant of Open Ring Metabolite of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: t1/2 of Open Ring Metabolite of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
measure: Part III: Ae of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae0-tau of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae0-24h of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
measure: Part III: Ae% of Meropenem, Calculated as Ae0-tau/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae% of Meropenem, Calculated as Ae0-24h/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
measure: Part III: CLr of Meropenem, Calculated as Ae0-tau/AUC0-tau
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion on Day 3
measure: Part III: CLr of Meropenem, Calculated as Ae0-24h/AUC0-24h
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
measure: Part III: Ae of Open Ring Metabolite of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae0-tau of Open Ring Metabolite of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae0-24h of Open Ring Metabolite of Meropenem
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
measure: Part III: Ae% of Open Ring Metabolite of Meropenem, Calculated as Ae0-tau/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
measure: Part III: Ae% of Open Ring Metabolite of Meropenem, Calculated as Ae0-24h/Dose
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
measure: Part III: CLr of Open Ring Metabolite of Meropenem, Calculated as Ae0-tau/AUC0-tau
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion on Day 3
measure: Part III: CLr of Open Ring Metabolite of Meropenem, Calculated as Ae0-24h/AUC0-24h
time frame: Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
arm group label: Part I: RO7079901
arm group type: Experimental
description: Participants will be randomized in two dose cohorts to receive single dose of RO7079901 1000 and 2000 milligrams (mg) intravenous (IV) infusion on Days 1 through Day 7 every 8 hours (q8h), for a total of 19 doses, with the last dose administered on the morning of Day 7.
arm group label: Part I: Placebo
arm group type: Placebo Comparator
description: Participants will be randomized in two dose cohorts to receive single dose of placebo matching to RO7079901 on Days 1 through Day 7 q8h, for a total of 19 doses, with the last dose administered on the morning of Day 7.
arm group label: Part II - Single Dose and Repeat Dose: RO7079901
arm group type: Experimental
description: Participants will be randomized in two dose cohorts to receive single dose of RO7079901 IV infusion at a dose above the previously studied dose levels in Part I (greater than [>] 2000 mg) on Day 1, with the option to extend to q8h dosing for 7 days (i.e., starting on Day 3 through Day 9); once PK, safety and tolerability have been confirmed up to 48 hrs after the single dose.
arm group label: Part II - Single Dose and Repeat Dose: Placebo
arm group type: Placebo Comparator
description: Participants will be randomized in two dose cohorts to receive single dose placebo matching to RO7079901 on Day 1, with the option to extend to q8h dosing for 7 days (i.e., starting on Day 3 through Day 9); once PK, safety and tolerability have been confirmed up to 48 hrs after the single dose.
arm group label: Part III: RO7079901 + Meropenem
arm group type: Experimental
description: Participants will be randomized in three dose cohorts to receive RO7079901 and Meropenem IV infusion in one of the 2 treatment sequences. Participants randomized to Sequence 1 will receive a single dose of 2000 mg meropenem IV infusion on Day 1. On Day 2, participants will receive a single dose of RO7079901 IV infusion. Participants randomized to Sequence 2 will receive a single dose of RO7079901 IV infusion on Day 1. On Day 2, participants will receive a single dose of 2000 mg meropenem IV infusion. Starting on Day 3 and continuing through Day 9 (i.e., for a total of 19 doses, last dose in the morning of Day 9) all participants will receive RO7079901 in combination with meropenem IV infusion q8h, regardless of sequence. Escalation to a maximum dose of RO7079901 5000 mg q8h may be considered on the basis of safety and tolerability data from the previous cohorts.
arm group label: Part III: RO7079901 Placebo + Meropenem Placebo
arm group type: Placebo Comparator
description: Participants will be randomized in three dose cohorts to receive RO7079901 and Meropenem matching placebos in one of the 2 treatment sequences. Participants randomized to Sequence 1 will receive a single dose of placebo matching to meropenem on Day 1. On Day 2, participants will receive a single dose of placebo matching to RO7079901. Participants randomized to Sequence 2 will receive a single dose of placebo matching to RO7079901 on Day 1. On Day 2, participants will receive a single dose of placebo matching to meropenem. Starting on Day 3 and continuing through Day 9 (i.e., for a total of 19 doses, last dose in the morning of Day 9) all participants will receive RO7079901 and meropenem matching placebos q8h, regardless of sequence.
intervention type: Drug
intervention name: RO7079901
description: RO7079901 will be administered as per schedule described in individual arm.
arm group label: Part I: RO7079901
arm group label: Part II - Single Dose and Repeat Dose: RO7079901
arm group label: Part III: RO7079901 + Meropenem
intervention type: Drug
intervention name: Meropenem
description: Meropenem will be administered as per schedule described in individual arm.
arm group label: Part III: RO7079901 + Meropenem
intervention type: Other
intervention name: RO7049389 Placebo
description: Placebo matching to RO7049389 will be administered as per schedule described in individual arm.
arm group label: Part I: Placebo
arm group label: Part II - Single Dose and Repeat Dose: Placebo
arm group label: Part III: RO7079901 Placebo + Meropenem Placebo
intervention type: Other
intervention name: Meropenem Placebo
description: Placebo matching to meropenem will be administered as per schedule described in individual arm.
arm group label: Part III: RO7079901 Placebo + Meropenem Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Meropenem