<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/NCT03291158</url>
  </required_header>
  <id_info>
    <org_study_id>MDCO-MIN-16-04</org_study_id>
    <nct_id>NCT03291158</nct_id>
  </id_info>
  <brief_title>Safety and PK Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Minocin IV</brief_title>
  <official_title>A Phase 1, Randomized, Open-Label Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous Minocin (Minocylcine) for Injection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universitätsklinikum Köln</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Innovative Medicines Initiative</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 1, safety and PK Open-Label trial evaluating the plasma, epithelial lining&#xD;
      fluid, and alveolar macrophage concentrations of intravenous Minocin® (Minocycline) for&#xD;
      injection in healthy adult subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the safety of Minocin IV and measure plasma,&#xD;
      epithelial lining fluid, and alveolar macrophage drug levels after six doses of Minocin IV&#xD;
      given 12 hours apart, administered as 1-hour infusions in healthy adult subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 2018</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 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>Analyze plasma, ELF and Alveolar Macrophage concentrations of minocycline</measure>
    <time_frame>16 weeks</time_frame>
    <description>Determine plasma ELF and Alveolar Macrophage concentrations of minocycline when administered to healthy adult subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability</measure>
    <time_frame>16 weeks</time_frame>
    <description>To assess the safety and tolerability of Minocin IV when administered to healthy adult subjects by assessing adverse events, changes from baseline in physical examination findings, clinical safety laboratory test results, ECGs, and vital signs throughout the study.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Normal Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Minocycline IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open label Minocin IV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Minocycline</intervention_name>
    <description>Subjects will be assigned into 5 cohorts of 5 subjects each, who will receive six doses of Minocin IV every 12 hours, starting on Day 1. Each dose of Minocin IV will be administered as an IV infusion over 1 hour. Subjects will be assigned to cohort based on time of bronchoalveolar lavage.</description>
    <arm_group_label>Minocycline IV</arm_group_label>
    <other_name>Minocin IV</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A signed informed consent form, the ability to understand the study conduct and tasks&#xD;
             that are required for study participation, and a willingness to cooperate with all&#xD;
             tasks, tests, and examinations as required by the protocol, whether in the hospital or&#xD;
             after discharge, for the duration of the study;&#xD;
&#xD;
          2. Healthy adult male or female between 18 and 55 years of age (inclusive) at the time of&#xD;
             Screening;&#xD;
&#xD;
          3. Body mass index (BMI) ≥ 18.5 and ≤ 30 (kg/m2) and weight between 55.0 and 100.0 kg&#xD;
             (inclusive) at Screening;&#xD;
&#xD;
          4. Subject is in good health based on medical history and physical examination findings&#xD;
             and has no clinically meaningful safety laboratory abnormalities (hematology, blood&#xD;
             chemistry, and urinalysis) or 12-lead ECG results, as assessed by the Principal&#xD;
             Investigator (PI);&#xD;
&#xD;
          5. Vital signs (blood pressure [BP], pulse, and temperature) measured at&#xD;
             Screening/baseline must be within the following ranges: systolic BP ≥90 to ≤150 mm Hg,&#xD;
             diastolic BP ≥45 to ≤90 mm Hg; Heart Rate ≥ 45 to ≤90 bpm (taken after resting in a&#xD;
             supine position for at least 5 minutes);&#xD;
&#xD;
          6. Expectation that intravenous access will be sufficient to allow for ease of study drug&#xD;
             infusion and for all protocol-required blood sampling to take place;&#xD;
&#xD;
          7. Subject commits to remaining under observation of the study staff for the course of&#xD;
             the study;&#xD;
&#xD;
          8. Female subject is surgically sterile (bilateral tubal occlusion), postmenopausal, or&#xD;
             if of childbearing potential, agrees to abstinence or to use a highly efficient method&#xD;
             of birth control (i.e., intrauterine device [IUD] or intrauterine hormone-releasing&#xD;
             system [IUS] or vasectomized male partner, or hormonal contraceptives [estrogen and&#xD;
             progestogen combined or progestogen only] with inhibition of ovulation; oral hormonal&#xD;
             contraceptives must be supplemented with the use of condoms), between inclusion and&#xD;
             for 7 days after the completion of the study;&#xD;
&#xD;
          9. If male, agree to be sexually abstinent or agree to use an approved method of&#xD;
             contraception (e.g., condom with spermicide) when engaging in sexual activity from&#xD;
             study check-in through 7 days after completion of the study, and to not donate sperm&#xD;
             during this same period of time.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has any condition, including findings in the medical history or in pre-study&#xD;
             assessments that constitutes a risk or a contraindication for the participation in the&#xD;
             study or completing the study;&#xD;
&#xD;
          2. Any acute illness, including clinically significant infection within 30 days prior to&#xD;
             Day 1;&#xD;
&#xD;
          3. Surgery within the past three months prior to Day 1 determined by the PI to be&#xD;
             clinically relevant;&#xD;
&#xD;
          4. Positive breath test for alcohol on Day 1 (pre-dose) and/or positive urine test for&#xD;
             drugs of abuse at Screening/Day -1 visit;&#xD;
&#xD;
          5. Has a history or presence of alcohol/drug abuse within 2 years. Alcohol abuse is&#xD;
             defined as regularly consuming &gt;3 units/day (21 units per week for men) and &gt;2&#xD;
             units/day (14 units/week) for women. A unit is defined as a can of 4% beer (330 mL),&#xD;
             approximately 190 mL of 6-7% beer (malt liquor), a glass of 40% spirits (30 mL), or a&#xD;
             glass of wine (100 mL);&#xD;
&#xD;
          6. Subject is a smoker and smokes &gt;5 cigarettes per day (or equivalent);&#xD;
&#xD;
          7. Use of non-tobacco/nicotine-containing products within 6 months prior to Day 1;&#xD;
&#xD;
          8. Current diagnosis of or positive at Screening for HIV and/or Hepatitis B;&#xD;
&#xD;
          9. Blood or plasma donation within past 2 months;&#xD;
&#xD;
         10. Females who are pregnant or nursing or who have a positive pregnancy test result at&#xD;
             Screening;&#xD;
&#xD;
         11. Presence of known raised intracranial pressure;&#xD;
&#xD;
         12. Use of isotretinoin;&#xD;
&#xD;
         13. History of significant hypersensitivity or allergic reaction to tetracycline&#xD;
             antibiotics;&#xD;
&#xD;
         14. History of allergic or other serious adverse reactions to lidocaine;&#xD;
&#xD;
         15. Clinically significant pulmonary or any other disease that prevents a subject from&#xD;
             undergoing bronchoscopy with bronchopulmonary lavage;&#xD;
&#xD;
         16. History of seizures (e.g., epilepsy), head injury, or meningitis requiring ongoing&#xD;
             anti-seizure medications;&#xD;
&#xD;
         17. Receipt of any investigational medication or investigational device during the last 30&#xD;
             days prior to randomization;&#xD;
&#xD;
         18. Vigorous exercise from 48 hours prior to Day -1 until the day of discharge from the&#xD;
             study;&#xD;
&#xD;
         19. Treatment with any prescription or over-the-counter drugs, within two weeks of day 1,&#xD;
             with the exception of acetaminophen/paracetamol for minor headache. Birth control or&#xD;
             other hormone replacement is also permitted as long as it has been taken at a stable&#xD;
             dose for at least three months before the Screening visit and remains stable for the&#xD;
             duration of the study;&#xD;
&#xD;
         20. Unable or unwilling to comply with the protocol;&#xD;
&#xD;
         21. An employee of the PI or study center with direct involvement in the proposed study or&#xD;
             other studies under the direction of that PI or study center, or a family member of&#xD;
             the employee or the PI&#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>Markus Zeitlinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Vienna</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jeffrey Loutit, MBChB</last_name>
    <phone>+1-650-888-5007</phone>
    <email>jeff.loutit@themedco.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Brooke Lohse</last_name>
    <phone>+1-858-875-6672</phone>
    <email>brooke.lohse@themedco.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>March 1, 2018</last_update_submitted>
  <last_update_submitted_qc>March 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bacterial Infections</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Minocycline</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/NCT03291158
org study id: MDCO-MIN-16-04
nct id: NCT03291158
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a phase 1, safety and PK Open-Label trial evaluating the plasma, epithelial lining
      fluid, and alveolar macrophage concentrations of intravenous Minocin® (Minocycline) for
      injection in healthy adult subjects.
The purpose of this study is to evaluate the safety of Minocin IV and measure plasma,
      epithelial lining fluid, and alveolar macrophage drug levels after six doses of Minocin IV
      given 12 hours apart, administered as 1-hour infusions in healthy adult subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Analyze plasma, ELF and Alveolar Macrophage concentrations of minocycline
time frame: 16 weeks
description: Determine plasma ELF and Alveolar Macrophage concentrations of minocycline when administered to healthy adult subjects.
measure: Safety and Tolerability
time frame: 16 weeks
description: To assess the safety and tolerability of Minocin IV when administered to healthy adult subjects by assessing adverse events, changes from baseline in physical examination findings, clinical safety laboratory test results, ECGs, and vital signs throughout the study.
arm group label: Minocycline IV
arm group type: Experimental
description: Open label Minocin IV
intervention type: Drug
intervention name: Minocycline
description: Subjects will be assigned into 5 cohorts of 5 subjects each, who will receive six doses of Minocin IV every 12 hours, starting on Day 1. Each dose of Minocin IV will be administered as an IV infusion over 1 hour. Subjects will be assigned to cohort based on time of bronchoalveolar lavage.
arm group label: Minocycline IV
other name: Minocin IV
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Markus Zeitlinger, MD
role: Principal Investigator
affiliation: University of Vienna
last name: Jeffrey Loutit, MBChB
phone: +1-650-888-5007
email: jeff.loutit@themedco.com
last name: Brooke Lohse
phone: +1-858-875-6672
email: brooke.lohse@themedco.com
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Minocycline
sharing ipd: No