<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/NCT02189304</url>
  </required_header>
  <id_info>
    <org_study_id>PT010002-00</org_study_id>
    <nct_id>NCT02189304</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Safety Study of PT010 in Healthy Subjects</brief_title>
  <official_title>A Phase I, Randomized, Double-Blind, Single-Dose, Three-Period, Three-Treatment, Cross-Over Study Evaluating the Pharmacokinetics and Safety of a Single Dose of PT010, a Single Dose of PT009, and a Single Dose of Open-Label Symbicort® Turbohaler® in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pearl Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pearl Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a single-center, Phase I, healthy adult subject study with a randomized, double&#xD;
      blind, three period, three-treatment, cross-over design.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2014</start_date>
  <completion_date type="Actual">September 1, 2014</completion_date>
  <primary_completion_date type="Actual">September 1, 2014</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Safety of PT010, PT009 and Symbicort Turbohaler</measure>
    <time_frame>12 hours post dose</time_frame>
    <description>The safety of PT010 and PT009 and Symbicort Turbohaler will be assessed based on physical examination, adverse events, vital signs, clinical laboratory values, and electrocardiogram</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>◦Maximum plasma concentration (Cmax) of PT010, PT009 and Symbicort Turbohaler</measure>
    <time_frame>12 Hour post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>◦Area under the curve from 0 to 12 hours (AUC0 12) of PT010, PT009 and Symbicort Turbohaler</measure>
    <time_frame>12 Hour post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>◦Area under the curve from 0 to the time of the last measureable plasma concentration (AUC0 t) of PT010, PT009 and Symbicort Turbohaler</measure>
    <time_frame>12 Hour post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>◦Area under the curve from 0 extrapolated to infinity (AUC0-∞) of PT010, PT009, and Symbicort Turbohaler</measure>
    <time_frame>12 Hour post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>◦Time to maximum plasma concentration (tmax) of PT010, PT009, and Symbicort Turbohaler</measure>
    <time_frame>12 Hour post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>◦Apparent terminal elimination half life (t½) of PT010, PT009, and Symbicort Turbohaler</measure>
    <time_frame>12 Hour post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>◦Apparent total body clearance (CL/F) of PT010, PT009, and Symbicort Turbohaler</measure>
    <time_frame>12 Hour post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>◦Apparent volume of distribution (Vd/F) of PT010, PT009, and Symbicort Turbohaler</measure>
    <time_frame>12 Hour post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>◦Termination elimination rate constant (λz) of PT010, PT009, and Symbicort Turbohaler</measure>
    <time_frame>12 Hour post dose</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>PT010</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PT009</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Symbicort Turbohaler</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PT010</intervention_name>
    <description>PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations</description>
    <arm_group_label>PT009</arm_group_label>
    <arm_group_label>Symbicort Turbohaler</arm_group_label>
    <other_name>PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PT009</intervention_name>
    <description>PT009 administered as 2 inhalations</description>
    <arm_group_label>PT010</arm_group_label>
    <arm_group_label>Symbicort Turbohaler</arm_group_label>
    <other_name>PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Symbicort Turbohaler</intervention_name>
    <description>Symbicort Turbohaler taken as 2 inhalations</description>
    <arm_group_label>PT009</arm_group_label>
    <arm_group_label>PT010</arm_group_label>
    <other_name>Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed Consent Form (ICF) prior to any study related procedures&#xD;
&#xD;
          -  Male and female subjects 18 to 55 years, inclusive&#xD;
&#xD;
          -  Good general health&#xD;
&#xD;
          -  Medically acceptable contraception for women of child-bearing potential and males with&#xD;
             female partners of childbearing potential&#xD;
&#xD;
          -  Clinical labs within normal ranges or determined to be not clinically significant by&#xD;
             the Investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, nursing female subjects, or subjects trying to conceive&#xD;
&#xD;
          -  Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic,&#xD;
             pulmonary, hematological, psychiatric, or other medical illness that would interfere&#xD;
             with participation in this study&#xD;
&#xD;
          -  History of ECG abnormalities&#xD;
&#xD;
          -  Cancer not in complete remission for at least 5 years&#xD;
&#xD;
          -  Clinically significant, symptomatic prostatic hypertrophy&#xD;
&#xD;
          -  Male subjects with a trans-urethral resection of the prostate or full resection of the&#xD;
             prostate within 6 months prior to Screening&#xD;
&#xD;
          -  Clinically significant bladder neck obstruction or urinary retention&#xD;
&#xD;
          -  Inadequately treated glaucoma&#xD;
&#xD;
          -  History of an allergic reaction or hypersensitivity to any drug or to any component of&#xD;
             the formulations used in this study&#xD;
&#xD;
          -  Subjects with pre-existing anemia and/or iron deficiency&#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>Chadwick Orevillo</last_name>
    <role>Study Chair</role>
    <affiliation>Pearl Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SNBL 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>June 2018</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>June 11, 2018</last_update_submitted>
  <last_update_submitted_qc>June 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Budesonide</mesh_term>
    <mesh_term>Glycopyrrolate</mesh_term>
    <mesh_term>Formoterol Fumarate</mesh_term>
    <mesh_term>Budesonide, Formoterol Fumarate Drug Combination</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/NCT02189304
org study id: PT010002-00
nct id: NCT02189304
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a single-center, Phase I, healthy adult subject study with a randomized, double
      blind, three period, three-treatment, cross-over design.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Overall Safety of PT010, PT009 and Symbicort Turbohaler
time frame: 12 hours post dose
description: The safety of PT010 and PT009 and Symbicort Turbohaler will be assessed based on physical examination, adverse events, vital signs, clinical laboratory values, and electrocardiogram
measure: ◦Maximum plasma concentration (Cmax) of PT010, PT009 and Symbicort Turbohaler
time frame: 12 Hour post dose
measure: ◦Area under the curve from 0 to 12 hours (AUC0 12) of PT010, PT009 and Symbicort Turbohaler
time frame: 12 Hour post dose
measure: ◦Area under the curve from 0 to the time of the last measureable plasma concentration (AUC0 t) of PT010, PT009 and Symbicort Turbohaler
time frame: 12 Hour post dose
measure: ◦Area under the curve from 0 extrapolated to infinity (AUC0-∞) of PT010, PT009, and Symbicort Turbohaler
time frame: 12 Hour post dose
measure: ◦Time to maximum plasma concentration (tmax) of PT010, PT009, and Symbicort Turbohaler
time frame: 12 Hour post dose
measure: ◦Apparent terminal elimination half life (t½) of PT010, PT009, and Symbicort Turbohaler
time frame: 12 Hour post dose
measure: ◦Apparent total body clearance (CL/F) of PT010, PT009, and Symbicort Turbohaler
time frame: 12 Hour post dose
measure: ◦Apparent volume of distribution (Vd/F) of PT010, PT009, and Symbicort Turbohaler
time frame: 12 Hour post dose
measure: ◦Termination elimination rate constant (λz) of PT010, PT009, and Symbicort Turbohaler
time frame: 12 Hour post dose
arm group label: PT010
arm group type: Experimental
description: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
arm group label: PT009
arm group type: Experimental
description: PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
arm group label: Symbicort Turbohaler
arm group type: Active Comparator
description: Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations
intervention type: Drug
intervention name: PT010
description: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
arm group label: PT009
arm group label: Symbicort Turbohaler
other name: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol
intervention type: Drug
intervention name: PT009
description: PT009 administered as 2 inhalations
arm group label: PT010
arm group label: Symbicort Turbohaler
other name: PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
intervention type: Drug
intervention name: Symbicort Turbohaler
description: Symbicort Turbohaler taken as 2 inhalations
arm group label: PT009
arm group label: PT010
other name: Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chadwick Orevillo
role: Study Chair
affiliation: Pearl Therapeutics
facility: 
country: United States
responsible party type: Sponsor
mesh term: Budesonide
mesh term: Glycopyrrolate
mesh term: Formoterol Fumarate
mesh term: Budesonide, Formoterol Fumarate Drug Combination