<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/NCT02197975</url>
  </required_header>
  <id_info>
    <org_study_id>PT010003-00</org_study_id>
    <nct_id>NCT02197975</nct_id>
  </id_info>
  <brief_title>Randomized, Crossover Safety and Pharmacokinetics Study of PT010</brief_title>
  <official_title>A Phase I, Randomized, Double Blind, Placebo-Controlled, Two Period, Ascending Dose, Crossover Study to Assess the Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese&#xD;
      Descent Following a Single Dose and After Chronic Dosing for 7 Days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase I, single-center, randomized, double-blind, placebo-controlled, two period,&#xD;
      ascending dose, cross-over study to assess safety and PK of two doses of PT010 in healthy&#xD;
      adult subjects of Japanese descent. Safety and PK will be assessed following a single dose&#xD;
      and during twice-daily (BID) chronic dosing for 7 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 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>The pharmacokinetic profile of PT010</measure>
    <time_frame>12 hours</time_frame>
    <description>The pharmacokinetic profile of PT010 will be assessed at the first day (Day 1) and last dose (Day 8) in each Treatment Period based on:&#xD;
maximum plasma concentration (Cmax)&#xD;
area under the plasma concentration-time curve from 0 to 12 hours (AUC0 12)&#xD;
area under the plasma concentration-time curve from 0 to the time of the last measureable plasma concentration (AUC0-t)&#xD;
area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) (only calculated for Day 1)&#xD;
time to maximum plasma concentration (tmax)&#xD;
apparent terminal elimination half-life (t½)&#xD;
apparent total body clearance (CL/F)&#xD;
apparent volume of distribution (Vd/F)&#xD;
terminal elimination rate constant (λz)&#xD;
accumulation ratio for Cmax (RAC [Cmax])&#xD;
accumulation ratio for AUC0 12 (RAC [AUC0 12]) Other PK parameters may be calculated, as appropriate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall safety of PT010</measure>
    <time_frame>12 hours</time_frame>
    <description>The safety associated with the use of PT010 will be assessed from physical examination findings, adverse event (AE) reporting, vital signs, clinical laboratory values, and findings from 12 lead electrocardiograms (ECGs).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>PT010 Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PT010 Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo MDI</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo MDI. Administered as 2 inhalations</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PT010 Dose 1</intervention_name>
    <description>PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.</description>
    <arm_group_label>PT010 Dose 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PT010 Dose 2</intervention_name>
    <description>PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.</description>
    <arm_group_label>PT010 Dose 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo MDI</intervention_name>
    <description>Placebo MDI. Administered as 2 inhalations</description>
    <arm_group_label>Placebo MDI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed Consent Form (ICF) prior to any study related procedures&#xD;
&#xD;
          -  Male and female subjects first generation Japanese subjects 18 to 55 years, inclusive&#xD;
&#xD;
          -  Body weight ≥50 kg (110 lbs) at the Screening Visit and body mass index between 18.5&#xD;
             and 32 kg/m2, 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>October 2014</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>October 27, 2014</last_update_submitted>
  <last_update_submitted_qc>October 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Volunteers</keyword>
  <!-- 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/NCT02197975
org study id: PT010003-00
nct id: NCT02197975
lead sponsor: 
has dmc: No
Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese
      Descent Following a Single Dose and After Chronic Dosing for 7 Days.
This is a Phase I, single-center, randomized, double-blind, placebo-controlled, two period,
      ascending dose, cross-over study to assess safety and PK of two doses of PT010 in healthy
      adult subjects of Japanese descent. Safety and PK will be assessed following a single dose
      and during twice-daily (BID) chronic dosing for 7 days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The pharmacokinetic profile of PT010
time frame: 12 hours
description: The pharmacokinetic profile of PT010 will be assessed at the first day (Day 1) and last dose (Day 8) in each Treatment Period based on:
maximum plasma concentration (Cmax)
area under the plasma concentration-time curve from 0 to 12 hours (AUC0 12)
area under the plasma concentration-time curve from 0 to the time of the last measureable plasma concentration (AUC0-t)
area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) (only calculated for Day 1)
time to maximum plasma concentration (tmax)
apparent terminal elimination half-life (t½)
apparent total body clearance (CL/F)
apparent volume of distribution (Vd/F)
terminal elimination rate constant (λz)
accumulation ratio for Cmax (RAC [Cmax])
accumulation ratio for AUC0 12 (RAC [AUC0 12]) Other PK parameters may be calculated, as appropriate.
measure: Overall safety of PT010
time frame: 12 hours
description: The safety associated with the use of PT010 will be assessed from physical examination findings, adverse event (AE) reporting, vital signs, clinical laboratory values, and findings from 12 lead electrocardiograms (ECGs).
arm group label: PT010 Dose 1
arm group type: Experimental
description: PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
arm group label: PT010 Dose 2
arm group type: Experimental
description: PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
arm group label: Placebo MDI
arm group type: Placebo Comparator
description: Placebo MDI. Administered as 2 inhalations
intervention type: Drug
intervention name: PT010 Dose 1
description: PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
arm group label: PT010 Dose 1
intervention type: Drug
intervention name: PT010 Dose 2
description: PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
arm group label: PT010 Dose 2
intervention type: Drug
intervention name: Placebo MDI
description: Placebo MDI. Administered as 2 inhalations
arm group label: Placebo MDI
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