<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/NCT03775668</url>
  </required_header>
  <id_info>
    <org_study_id>AT-104</org_study_id>
    <nct_id>NCT03775668</nct_id>
  </id_info>
  <brief_title>Single Dose Mass Balance Study With C14 - Labeled AAI101 in Healthy Male Volunteers</brief_title>
  <official_title>A Phase 1, Open-Label, Single-Dose Study to Assess the Mass Balance, Pharmacokinetics and Metabolism of Intravenously Administered 14C-AAI101 in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allecra</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allecra</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 an open-label, single dose, pharmacokinetic (PK) study conducted at 1 study center in&#xD;
      the United States (USA). This study will evaluate the absorption, distribution, metabolism,&#xD;
      and elimination (ADME), mass balance, safety, and tolerability of a single dose of&#xD;
      intravenously administered 14C-AAI101.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2018</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 5, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Concentrations of total radiolabelled 14C-content in blood, plasma, urine, and feces.</measure>
    <time_frame>Up to 7 days post dosing</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of parent AAI101 in plasma and urine.</measure>
    <time_frame>Up to 7 days post dosing</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metabolite profiling for pooled plasma, urine and feces If &gt; 10% of total radioactivity is recovered in the respective excreta sample/collection.</measure>
    <time_frame>Up to 7 days post dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculation of cumulative urinary and fecal recovery of total radioactivity, and calculation of mass balance as a sum of the percentages of total radioactivity recovered in urine and feces.</measure>
    <time_frame>Up to 7 days post dosing</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>1 µCi of 14C-AAI101 + 500 mg AAI101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>14C-AAI101 + 500 mg AAI101 iv infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1 µCi of 14C-AAI101 + 500 mg AAI101</intervention_name>
    <description>Single dose open label</description>
    <arm_group_label>1 µCi of 14C-AAI101 + 500 mg AAI101</arm_group_label>
    <other_name>14C-AAI101 + 500 mg AAI101 iv infusion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to understand and willing to sign the Informed Consent Form (ICF)&#xD;
&#xD;
          2. BMI 18.0 - 35.0 kg/m2, inclusive,&#xD;
&#xD;
          3. Subjects with normal renal function as evidenced by creatinine clearance (CLcr).&#xD;
&#xD;
          4. Judged to be in good health in the opinion of the Investigator on the basis of a&#xD;
             medical evaluation that reveals the absence of any clinically significant abnormality&#xD;
&#xD;
          5. Content of 14C in one or both (at Investigator's discretion) of urine and blood (or&#xD;
             plasma) samples obtained at Screening does not significantly exceed the general&#xD;
             environmental background 14C level.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically significant abnormal medical history, abnormal findings on physical&#xD;
             examination, vital signs, ECG, or laboratory tests at Screening, Day -1 or pre-dose on&#xD;
             Day 1 that the Investigator judges may put at risk achieving the objectives of the&#xD;
             trial or protecting the safety of the volunteer.&#xD;
&#xD;
          2. Documented congenital or acquired long QT syndrome.&#xD;
&#xD;
          3. Corrected QT interval (QTc) using Fridericia correction (QTcF) at Screening or pre&#xD;
             dose (Day 1) &gt;450 ms.&#xD;
&#xD;
          4. Family history of long QT syndrome or of unexplained sudden death in a first-degree&#xD;
             relative under age 50.&#xD;
&#xD;
          5. History of multiple and/or severe allergies to drugs or foods or a history of&#xD;
             anaphylactic reaction.&#xD;
&#xD;
          6. History of cancer judged not to be in full remission for at least 5 years (except&#xD;
             basal cell skin cancer or squamous cell skin cancer with history of curative treatment&#xD;
             and no recurrence for at least 1 year), as judged by the Investigator.&#xD;
&#xD;
          7. History of active alcoholism or drug abuse within the last 2 years prior to study drug&#xD;
             administration. Acceptable use history is typical consumption of up to 14 units per&#xD;
             week (1 unit equals 250 mL beer, 75 mL wine, 25 mL spirits per week), or per judgment&#xD;
             of the Investigator.&#xD;
&#xD;
          8. Regular alcohol consumption in males &gt;14 units per week (1 unit = ½ pint beer, or a 25&#xD;
             mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type).&#xD;
&#xD;
          9. Recent history of incomplete bladder emptying with voiding or of awaking more than&#xD;
             once at night to void.&#xD;
&#xD;
         10. Usual habit of less than one or more than three bowel movements per day.&#xD;
&#xD;
         11. Acute illness within 14 days prior to study drug administration unless mild in&#xD;
             severity and enrollment is approved by both Investigator and Sponsor's medical&#xD;
             representative.&#xD;
&#xD;
         12. Presence of active infection requiring antibiotic treatment.&#xD;
&#xD;
         13. Concomitant or prior use (within 60 days prior to study drug administration) of&#xD;
             medications known to affect the elimination of serum creatinine (e.g., trimethoprim or&#xD;
             cimetidine) or to compete for renal tubular secretion (e.g., probenecid).&#xD;
&#xD;
         14. Allergy, hypersensitivity or intolerance to β-lactam antibiotics and/or&#xD;
             cephalosporin-class antibiotics in the medical history.&#xD;
&#xD;
         15. Current smokers and those who have smoked within the last 12 months; this includes&#xD;
             cigarettes, e-cigarettes and nicotine replacement or nicotine containing products.&#xD;
&#xD;
         16. Participation in another investigational drug trial within 30 days prior to study drug&#xD;
             administration (or 5 times the half-life of the drug, whichever is longer) or exposure&#xD;
             to more than three new investigational agents within 12 months prior to study drug&#xD;
             administration.&#xD;
&#xD;
         17. Exposure to radiation for therapeutic or diagnostic reasons (except dental X-rays and&#xD;
             plain X-rays of thorax and bony skeleton) within the last 12 months prior to dosing of&#xD;
             the investigational drug, or an occupationally exposed worker&#xD;
&#xD;
         18. Participation in another clinical trial in which a [14C]-labeled drug was administered&#xD;
             within the year prior to Day -1.&#xD;
&#xD;
         19. Donation or loss of more than 450 mL blood during the 3 months before the start of and&#xD;
             during Screening.&#xD;
&#xD;
         20. Serum Alkaline phosphatase (AP) &gt; 1.5x upper limit of normal (ULN).&#xD;
&#xD;
         21. Serum transaminase [alanine aminotransferase (ALT) or aspartate aminotransferase&#xD;
             (AST)] &gt; ULN.&#xD;
&#xD;
         22. Serum uric acid &gt; ULN.&#xD;
&#xD;
         23. Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody&#xD;
             (anti HCV) or human immunodeficiency virus antibodies (anti-HIV)-1/2 at Screening.&#xD;
&#xD;
         24. Positive urine screen of drugs of abuse or alcohol breath test at Screening and/or Day&#xD;
             1.&#xD;
&#xD;
         25. Strenuous or unaccustomed activity, sunbathing, or contact sports within 96 hours (4&#xD;
             days) prior to entry in the clinic research center.&#xD;
&#xD;
         26. Legal incapacity or limited legal capacity.&#xD;
&#xD;
         27. Any clinically significant medical condition, i.e., one which in the opinion of the&#xD;
             Investigator would increase risk to the subject's health if participating in this&#xD;
             study or would increase risk of not achieving the study objectives.&#xD;
&#xD;
         28. Use of any prescription or non-prescription drugs, including over-the-counter&#xD;
             medication, non-routine vitamins and herbal products within 2 weeks prior to study&#xD;
             drug administration unless discussed and agreed with the Sponsor's medical&#xD;
             representative in writing.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pharmaron Clinical Pharmacology Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</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>Enmetazobactam</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03775668
org study id: AT-104
nct id: NCT03775668
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is an open-label, single dose, pharmacokinetic (PK) study conducted at 1 study center in
      the United States (USA). This study will evaluate the absorption, distribution, metabolism,
      and elimination (ADME), mass balance, safety, and tolerability of a single dose of
      intravenously administered 14C-AAI101.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Concentrations of total radiolabelled 14C-content in blood, plasma, urine, and feces.
time frame: Up to 7 days post dosing
measure: Concentration of parent AAI101 in plasma and urine.
time frame: Up to 7 days post dosing
measure: Metabolite profiling for pooled plasma, urine and feces If > 10% of total radioactivity is recovered in the respective excreta sample/collection.
time frame: Up to 7 days post dosing
measure: Calculation of cumulative urinary and fecal recovery of total radioactivity, and calculation of mass balance as a sum of the percentages of total radioactivity recovered in urine and feces.
time frame: Up to 7 days post dosing
arm group label: 1 µCi of 14C-AAI101 + 500 mg AAI101
arm group type: Experimental
description: 14C-AAI101 + 500 mg AAI101 iv infusion
intervention type: Drug
intervention name: 1 µCi of 14C-AAI101 + 500 mg AAI101
description: Single dose open label
arm group label: 1 µCi of 14C-AAI101 + 500 mg AAI101
other name: 14C-AAI101 + 500 mg AAI101 iv infusion
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Enmetazobactam
sharing ipd: No