<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/NCT02214433</url>
  </required_header>
  <id_info>
    <org_study_id>Debio 1450-103</org_study_id>
    <secondary_id>217595</secondary_id>
    <nct_id>NCT02214433</nct_id>
    <nct_alias>NCT02214355</nct_alias>
  </id_info>
  <brief_title>A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers</brief_title>
  <official_title>A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Debio 1450 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Debiopharm International SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Debiopharm International SA</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Debio 1450-103 is a trial to study the pharmacokinetics (PK) of an experimental drug called&#xD;
      Debio 1450 in healthy adult volunteers. Originally, Part A was registered separately (in&#xD;
      NCT02214355). The registrations have been revised so all parts of this single trial (Parts&#xD;
      A-C) are now included in this single registration (NCT02214433).&#xD;
&#xD;
      The primary purpose of each part is provided below:&#xD;
&#xD;
        -  10 volunteers participate in PART A to assess the PK of a single oral dose of Debio 1450&#xD;
           (tablet formulation) under varying gastric conditions&#xD;
&#xD;
        -  40 volunteers participate in PART B to assess the safety, tolerability and PK of&#xD;
           multiple ascending doses of Debio 1450, administered sequentially IV and orally, once or&#xD;
           twice daily.&#xD;
&#xD;
        -  An additional 10 volunteers participate in PART C which is designed to assess the&#xD;
           absolute bioavailability of various formulations of Debio 1450 under varying gastric&#xD;
           conditions&#xD;
&#xD;
      The dose administered during Part A is based on the safety, tolerability and PK data from&#xD;
      study Debio 1450-102 [NCT02162199], a single ascending dose (SAD) study, in which single oral&#xD;
      doses up to 800 mg/day are being investigated. Doses are adjusted during Parts B and C based&#xD;
      on the available safety and PK data from preceding cohorts.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with clinically significant change from baseline in safety parameters</measure>
    <time_frame>within 10 days post-dose</time_frame>
    <description>Categories: vital signs, 12-lead electrocardiogram (ECG), clinical laboratory parameters, adverse events, pulmonary function, physical examination, concomitant medication</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of Debio 1450 (prodrug) and Debio 1452 (active moiety)</measure>
    <time_frame>within 60 hours post-dose, depending on the assessment schedule for the cohort</time_frame>
    <description>Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of maximum observed plasma concentration (tmax) of Debio 1450 and Debio 1452</measure>
    <time_frame>within 60 hours post-dose, depending on the assessment schedule for the cohort</time_frame>
    <description>Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC) of Debio 1450 and Debio 1452</measure>
    <time_frame>within 60 hours post-dose, depending on the assessment schedule for the cohort</time_frame>
    <description>Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of AUC(0-o) that is due to extrapolation beyond the last quantifiable concentration measurement (%AUCex) of Debio 1450 and Debio 1452</measure>
    <time_frame>within 60 hours post-dose, depending on the assessment schedule for the cohort</time_frame>
    <description>Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Elimination half-life (t1/2) of Debio 1450 and Debio 1452</measure>
    <time_frame>within 60 hours post-dose, depending on the assessment schedule for the cohort</time_frame>
    <description>Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal elimination rate constant (Az) of Debio 1450 and Debio 1452</measure>
    <time_frame>within 60 hours post-dose, depending on the assessment schedule for the cohort</time_frame>
    <description>Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean residence time (MRT) of Debio 1450 and Debio 1452</measure>
    <time_frame>within 60 hours post-dose, depending on the assessment schedule for the cohort</time_frame>
    <description>Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent clearance following oral administration (CL/F) of Debio 1450 and Debio 1452</measure>
    <time_frame>within 60 hours post-dose, depending on the assessment schedule for the cohort</time_frame>
    <description>Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution of Debio 1450 and Debio 1452 during terminal phase (Vz/F)</measure>
    <time_frame>within 60 hours post-dose, depending on the assessment schedule for the cohort</time_frame>
    <description>Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae)</measure>
    <time_frame>within 60 hours post-dose, depending on the assessment schedule for the cohort</time_frame>
    <description>Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae%)</measure>
    <time_frame>within 60 hours post-dose, depending on the assessment schedule for the cohort</time_frame>
    <description>Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal clearance following oral administration</measure>
    <time_frame>within 60 hours post-dose, depending on the assessment schedule for the cohort</time_frame>
    <description>Categories: Placebo Tablet or Capsule, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution</description>
  </primary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Bacterial Infections</condition>
  <arm_group>
    <arm_group_label>Part A Period 1 Debio 1450 IV Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A Debio 1450 IV solution infused over two hours on Day 1 after fasting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A Period 2 Debio 1450 Tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Debio 1450 Tablet oral dosing once on Day 5, after fasting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A Period 3 Debio 1450 Tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Debio 1450 Tablet oral dosing once on Day 9, 30 minutes after a high calorie, high fat breakfast, after fasting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A Period 4 Debio 1450 Tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After preparation with Pantoprazole, Pantoprazole taken with Debio 1450 Tablet oral dosing once on Day 14, after fasting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Placebo All Cohorts</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo IV solution on days 1-5 and then Placebo Tablet or Capsule on Days 6-10, according to the cohort dosing schedule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Debio 1450 Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Tablet, once daily on days 6-10</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Debio 1450 Cohort 2a</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Debio 1450 IV solution, once daily on day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Debio 1450 Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Debio 1450 Cohort 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Debio 1450 Cohort 2b</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Capsule, once daily on days 6-10</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C Debio 1450</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Debio 1450 (IV formulation in Period 1, capsule formulation in Periods 2, 4 and 5 (with Pantoprazole), and Debio 1450 oral solution in Period 3).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo IV Solution</intervention_name>
    <description>A sterile IV solution of 5% dextrose in water</description>
    <arm_group_label>Part B Placebo All Cohorts</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Debio 1450 IV Solution</intervention_name>
    <description>A white to off-white powder (40 mg Debio 1450 per vial) to be reconstituted and formulated in a sterile IV solution of 5% dextrose in water</description>
    <arm_group_label>Part A Period 1 Debio 1450 IV Solution</arm_group_label>
    <arm_group_label>Part B Debio 1450 Cohort 1</arm_group_label>
    <arm_group_label>Part B Debio 1450 Cohort 2a</arm_group_label>
    <arm_group_label>Part B Debio 1450 Cohort 2b</arm_group_label>
    <arm_group_label>Part B Debio 1450 Cohort 3</arm_group_label>
    <arm_group_label>Part B Debio 1450 Cohort 4</arm_group_label>
    <arm_group_label>Part C Debio 1450</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Tablet or Capsule</intervention_name>
    <description>Placebo tablet or capsule, matching Debio 1450 coated tablet or capsule</description>
    <arm_group_label>Part B Placebo All Cohorts</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Debio 1450 Tablet</intervention_name>
    <description>Debio 1450 40 mg coated tablets</description>
    <arm_group_label>Part A Period 2 Debio 1450 Tablet</arm_group_label>
    <arm_group_label>Part A Period 3 Debio 1450 Tablet</arm_group_label>
    <arm_group_label>Part A Period 4 Debio 1450 Tablet</arm_group_label>
    <arm_group_label>Part B Debio 1450 Cohort 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Debio 1450 Capsule</intervention_name>
    <description>Debio 1450 40 mg capsules</description>
    <arm_group_label>Part B Debio 1450 Cohort 2b</arm_group_label>
    <arm_group_label>Part B Debio 1450 Cohort 3</arm_group_label>
    <arm_group_label>Part B Debio 1450 Cohort 4</arm_group_label>
    <arm_group_label>Part C Debio 1450</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Debio 1450 Oral Solution</intervention_name>
    <description>Lyophilized Debio 1450 (40 mg per vial) reconstituted in 5% dextrose in water</description>
    <arm_group_label>Part C Debio 1450</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pantoprazole</intervention_name>
    <description>Pantoprazole 40 mg orally</description>
    <arm_group_label>Part A Period 4 Debio 1450 Tablet</arm_group_label>
    <arm_group_label>Part C Debio 1450</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meets protocol-specified criteria for qualification and/or contraception&#xD;
&#xD;
          -  Is willing and able to remain confined in the study unit for the entire duration of&#xD;
             each treatment period and comply with restrictions related to food, drink and&#xD;
             medications&#xD;
&#xD;
          -  Voluntarily consents to participate and provides written informed consent prior to any&#xD;
             protocol-specific procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a history or current use of over-the-counter medications, dietary supplements, or&#xD;
             drugs (including nicotine and alcohol) outside protocol-specified parameters&#xD;
&#xD;
          -  Has signs, symptoms or history of any condition that, per protocol or in the opinion&#xD;
             of the investigator, might compromise:&#xD;
&#xD;
               1. the safety or well-being of the participant or study staff&#xD;
&#xD;
               2. the safety or well-being of the participant's offspring (such as through&#xD;
                  pregnancy or breast-feeding)&#xD;
&#xD;
               3. the analysis of results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederick Wittke, MD</last_name>
    <role>Study Director</role>
    <affiliation>Debiopharm International SA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Early Phase Clinical Unit</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>February 24, 2015</last_update_submitted>
  <last_update_submitted_qc>February 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Antibiotic</keyword>
  <keyword>Antibiotic Resistant Bacterial Infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacterial Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pantoprazole</mesh_term>
    <mesh_term>Pharmaceutical Solutions</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/NCT02214433
org study id: Debio 1450-103
secondary id: 217595
nct id: NCT02214433
nct alias: NCT02214355
lead sponsor: 
has dmc: Yes
Debio 1450-103 is a trial to study the pharmacokinetics (PK) of an experimental drug called
      Debio 1450 in healthy adult volunteers. Originally, Part A was registered separately (in
      NCT02214355). The registrations have been revised so all parts of this single trial (Parts
      A-C) are now included in this single registration (NCT02214433).

      The primary purpose of each part is provided below:

        -  10 volunteers participate in PART A to assess the PK of a single oral dose of Debio 1450
           (tablet formulation) under varying gastric conditions

        -  40 volunteers participate in PART B to assess the safety, tolerability and PK of
           multiple ascending doses of Debio 1450, administered sequentially IV and orally, once or
           twice daily.

        -  An additional 10 volunteers participate in PART C which is designed to assess the
           absolute bioavailability of various formulations of Debio 1450 under varying gastric
           conditions

      The dose administered during Part A is based on the safety, tolerability and PK data from
      study Debio 1450-102 [NCT02162199], a single ascending dose (SAD) study, in which single oral
      doses up to 800 mg/day are being investigated. Doses are adjusted during Parts B and C based
      on the available safety and PK data from preceding cohorts.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Number of participants with clinically significant change from baseline in safety parameters
time frame: within 10 days post-dose
description: Categories: vital signs, 12-lead electrocardiogram (ECG), clinical laboratory parameters, adverse events, pulmonary function, physical examination, concomitant medication
measure: Maximum observed plasma concentration (Cmax) of Debio 1450 (prodrug) and Debio 1452 (active moiety)
time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
description: Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
measure: Time of maximum observed plasma concentration (tmax) of Debio 1450 and Debio 1452
time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
description: Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
measure: Area under the plasma concentration-time curve (AUC) of Debio 1450 and Debio 1452
time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
description: Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
measure: Percentage of AUC(0-o) that is due to extrapolation beyond the last quantifiable concentration measurement (%AUCex) of Debio 1450 and Debio 1452
time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
description: Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
measure: Elimination half-life (t1/2) of Debio 1450 and Debio 1452
time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
description: Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
measure: Terminal elimination rate constant (Az) of Debio 1450 and Debio 1452
time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
description: Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
measure: Mean residence time (MRT) of Debio 1450 and Debio 1452
time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
description: Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
measure: Apparent clearance following oral administration (CL/F) of Debio 1450 and Debio 1452
time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
description: Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
measure: Apparent volume of distribution of Debio 1450 and Debio 1452 during terminal phase (Vz/F)
time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
description: Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
measure: Cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae)
time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
description: Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
measure: Percentage of cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae%)
time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
description: Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
measure: Renal clearance following oral administration
time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
description: Categories: Placebo Tablet or Capsule, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
arm group label: Part A Period 1 Debio 1450 IV Solution
arm group type: Experimental
description: Part A Debio 1450 IV solution infused over two hours on Day 1 after fasting
arm group label: Part A Period 2 Debio 1450 Tablet
arm group type: Experimental
description: Debio 1450 Tablet oral dosing once on Day 5, after fasting
arm group label: Part A Period 3 Debio 1450 Tablet
arm group type: Experimental
description: Debio 1450 Tablet oral dosing once on Day 9, 30 minutes after a high calorie, high fat breakfast, after fasting
arm group label: Part A Period 4 Debio 1450 Tablet
arm group type: Experimental
description: After preparation with Pantoprazole, Pantoprazole taken with Debio 1450 Tablet oral dosing once on Day 14, after fasting
arm group label: Part B Placebo All Cohorts
arm group type: Placebo Comparator
description: Placebo IV solution on days 1-5 and then Placebo Tablet or Capsule on Days 6-10, according to the cohort dosing schedule
arm group label: Part B Debio 1450 Cohort 1
arm group type: Experimental
description: Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Tablet, once daily on days 6-10
arm group label: Part B Debio 1450 Cohort 2a
arm group type: Experimental
description: Debio 1450 IV solution, once daily on day 1
arm group label: Part B Debio 1450 Cohort 3
arm group type: Experimental
description: Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10
arm group label: Part B Debio 1450 Cohort 4
arm group type: Experimental
description: Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10
arm group label: Part B Debio 1450 Cohort 2b
arm group type: Experimental
description: Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Capsule, once daily on days 6-10
arm group label: Part C Debio 1450
arm group type: Experimental
description: Debio 1450 (IV formulation in Period 1, capsule formulation in Periods 2, 4 and 5 (with Pantoprazole), and Debio 1450 oral solution in Period 3).
intervention type: Drug
intervention name: Placebo IV Solution
description: A sterile IV solution of 5% dextrose in water
arm group label: Part B Placebo All Cohorts
intervention type: Drug
intervention name: Debio 1450 IV Solution
description: A white to off-white powder (40 mg Debio 1450 per vial) to be reconstituted and formulated in a sterile IV solution of 5% dextrose in water
arm group label: Part A Period 1 Debio 1450 IV Solution
arm group label: Part B Debio 1450 Cohort 1
arm group label: Part B Debio 1450 Cohort 2a
arm group label: Part B Debio 1450 Cohort 2b
arm group label: Part B Debio 1450 Cohort 3
arm group label: Part B Debio 1450 Cohort 4
arm group label: Part C Debio 1450
intervention type: Drug
intervention name: Placebo Tablet or Capsule
description: Placebo tablet or capsule, matching Debio 1450 coated tablet or capsule
arm group label: Part B Placebo All Cohorts
intervention type: Drug
intervention name: Debio 1450 Tablet
description: Debio 1450 40 mg coated tablets
arm group label: Part A Period 2 Debio 1450 Tablet
arm group label: Part A Period 3 Debio 1450 Tablet
arm group label: Part A Period 4 Debio 1450 Tablet
arm group label: Part B Debio 1450 Cohort 1
intervention type: Drug
intervention name: Debio 1450 Capsule
description: Debio 1450 40 mg capsules
arm group label: Part B Debio 1450 Cohort 2b
arm group label: Part B Debio 1450 Cohort 3
arm group label: Part B Debio 1450 Cohort 4
arm group label: Part C Debio 1450
intervention type: Drug
intervention name: Debio 1450 Oral Solution
description: Lyophilized Debio 1450 (40 mg per vial) reconstituted in 5% dextrose in water
arm group label: Part C Debio 1450
intervention type: Drug
intervention name: Pantoprazole
description: Pantoprazole 40 mg orally
arm group label: Part A Period 4 Debio 1450 Tablet
arm group label: Part C Debio 1450
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frederick Wittke, MD
role: Study Director
affiliation: Debiopharm International SA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bacterial Infections
mesh term: Pantoprazole
mesh term: Pharmaceutical Solutions