<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/NCT03270553</url>
  </required_header>
  <id_info>
    <org_study_id>ACHN-490-011</org_study_id>
    <nct_id>NCT03270553</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin</brief_title>
  <official_title>A Phase 1, Open Label, Randomized, 2-Period, 2-Treatment, Crossover Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Achaogen, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Achaogen, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover&#xD;
      study to evaluate the drug-drug interaction potential between plazomicin and metformin in&#xD;
      healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2017</start_date>
  <completion_date type="Actual">October 7, 2017</completion_date>
  <primary_completion_date type="Actual">October 7, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics of metformin in plasma</measure>
    <time_frame>9 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of adverse events</measure>
    <time_frame>15 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)</measure>
    <time_frame>8 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)</measure>
    <time_frame>9 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of metformin in urine</measure>
    <time_frame>9 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of plazomicin in plasma</measure>
    <time_frame>9 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>plazomicin</intervention_name>
    <description>single intravenous dose</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>metformin</intervention_name>
    <description>single oral dose</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Medically healthy, with no clinically significant medical history, physical&#xD;
             examination findings, vital signs, or ECG findings&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Estimated creatinine clearance &lt;90 mL/min&#xD;
&#xD;
          -  Use of tobacco- or nicotine-containing products&#xD;
&#xD;
          -  History in the past 90 days of prior trauma to the outer or internal structures of the&#xD;
             ear or tinnitus&#xD;
&#xD;
          -  History or family history of vestibular disorder, chronic vertigo (sensation of&#xD;
             spinning), chronic dizziness&#xD;
&#xD;
          -  History of hearing loss or a family history of hearing loss, or a prior diagnosis of&#xD;
             sensorineural hearing loss or Ménière's disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shyeilla Dhuria</last_name>
    <role>Study Director</role>
    <affiliation>Achaogen, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>October 9, 2017</last_update_submitted>
  <last_update_submitted_qc>October 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 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>Metformin</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/NCT03270553
org study id: ACHN-490-011
nct id: NCT03270553
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover
      study to evaluate the drug-drug interaction potential between plazomicin and metformin in
      healthy subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetics of metformin in plasma
time frame: 9 days
measure: Incidence and severity of adverse events
time frame: 15 days
measure: Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)
time frame: 8 days
measure: Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)
time frame: 9 days
measure: Pharmacokinetics of metformin in urine
time frame: 9 days
measure: Pharmacokinetics of plazomicin in plasma
time frame: 9 days
arm group label: Sequence 1
arm group type: Experimental
description: In Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin
arm group label: Sequence 2
arm group type: Experimental
description: In Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone
intervention type: Drug
intervention name: plazomicin
description: single intravenous dose
arm group label: Sequence 1
arm group label: Sequence 2
intervention type: Drug
intervention name: metformin
description: single oral dose
arm group label: Sequence 1
arm group label: Sequence 2
criteria: 
gender: All
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shyeilla Dhuria
role: Study Director
affiliation: Achaogen, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Metformin