xml: <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/NCT05999942</url>
    </required_header>
    <id_info>
      <org_study_id>RD 201/23924</org_study_id>
      <nct_id>NCT05999942</nct_id>
    </id_info>
    <brief_title>A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male Participants</brief_title>
    <official_title>A Gamma Scintigraphy Study to Investigate the Lung Deposition of Inhaled Amikacin-Loaded Liposomes in Healthy Male Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Insmed Incorporated</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Insmed Incorporated</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary purpose of this study is to determine the intra and extra pulmonary deposition&#xD;
        and clearance of inhaled amikacin-loaded liposomes by gamma scintigraphy in healthy male&#xD;
        participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 2, 2004</start_date>
    <completion_date type="Actual">June 29, 2004</completion_date>
    <primary_completion_date type="Actual">June 29, 2004</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>Pulmonary Deposition of Radiolabelled Amikacin-loaded Liposomes Measured as Percentage Retention of Emitted Dose Deposited in the Lungs</measure>
      <time_frame>Pre-administration and 2 hours post-administration on Day 1</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percent Dose Deposited in Oropharyngeal and Stomach Region</measure>
      <time_frame>At multiple timepoints post-administration up to Day 2</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Dose Remaining in the Device Including the Mouthpiece</measure>
      <time_frame>At multiple timepoints post-administration up to Day 2</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Dose Remaining in the Low Resistance Exhalation Filter</measure>
      <time_frame>At multiple timepoints post-administration up to Day 2</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Penetration Index Based on the Ratio of Counts in the Central:Peripheral Lung Regions, Corrected for Regional Lung Volume (sC/P)</measure>
      <time_frame>Pre-administration and 2 hours post- administration on Day 1</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">6</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Amikacin Liposome Inhalation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single dose of radiolabelled amikacin loaded liposomes by inhalation on Day 1.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Liposomal Amikacin for Inhalation</intervention_name>
      <description>Administered via the Pari LC STAR™ nebulizer.</description>
      <arm_group_label>Amikacin Liposome Inhalation</arm_group_label>
      <other_name>Amikacin Liposome Inhalation Suspension (ALIS),</other_name>
      <other_name>Arikayce™</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants with a body mass index (BMI) of 20-28.&#xD;
  &#xD;
            -  Participants with negative human immunodeficiency virus (HIV) and Hepatitis B and C&#xD;
               results.&#xD;
  &#xD;
            -  Participants with no clinically significant findings in 12-lead electrocardiogram&#xD;
               (ECG) determined within 14 days of the start of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants who had clinically diagnosed asthma.&#xD;
  &#xD;
            -  Participants with a known allergic reaction to amikacin, liposomes or any of the&#xD;
               radiolabelling products (i.e. [^99m]Tc, or [^111]In, and [^81m]Kr).&#xD;
  &#xD;
            -  Evidence of clinically significant pulmonary, renal, hepatic, cardiovascular or&#xD;
               metabolic dysfunction.&#xD;
  &#xD;
            -  History of smoking within the past 12 months.&#xD;
  &#xD;
            -  History of chronic cough or wheezing within the previous 21 days.&#xD;
  &#xD;
            -  Participants who had an upper respiratory illness or infection within the previous 21&#xD;
               days.&#xD;
  &#xD;
            -  A history of drug or alcohol abuse.&#xD;
  &#xD;
            -  Donation of 450 milliliters (mL) or more blood within the previous 12 weeks.&#xD;
  &#xD;
          Note: Other inclusion/exclusion criteria may apply.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>Amikacin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999942
  org study id: RD 201/23924
  nct id: NCT05999942
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The primary purpose of this study is to determine the intra and extra pulmonary deposition
        and clearance of inhaled amikacin-loaded liposomes by gamma scintigraphy in healthy male
        participants.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pulmonary Deposition of Radiolabelled Amikacin-loaded Liposomes Measured as Percentage Retention of Emitted Dose Deposited in the Lungs
  time frame: Pre-administration and 2 hours post-administration on Day 1
  measure: Percent Dose Deposited in Oropharyngeal and Stomach Region
  time frame: At multiple timepoints post-administration up to Day 2
  measure: Percent Dose Remaining in the Device Including the Mouthpiece
  time frame: At multiple timepoints post-administration up to Day 2
  measure: Percent Dose Remaining in the Low Resistance Exhalation Filter
  time frame: At multiple timepoints post-administration up to Day 2
  measure: Penetration Index Based on the Ratio of Counts in the Central:Peripheral Lung Regions, Corrected for Regional Lung Volume (sC/P)
  time frame: Pre-administration and 2 hours post- administration on Day 1
  arm group label: Amikacin Liposome Inhalation
  arm group type: Experimental
  description: Participants will receive a single dose of radiolabelled amikacin loaded liposomes by inhalation on Day 1.
  intervention type: Drug
  intervention name: Liposomal Amikacin for Inhalation
  description: Administered via the Pari LC STAR™ nebulizer.
  arm group label: Amikacin Liposome Inhalation
  other name: Amikacin Liposome Inhalation Suspension (ALIS),
  other name: Arikayce™
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor
  mesh term: Amikacin
  sharing ipd: No