<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/NCT02258321</url>
  </required_header>
  <id_info>
    <org_study_id>PPI-668-104</org_study_id>
    <nct_id>NCT02258321</nct_id>
  </id_info>
  <brief_title>Phase 1 Study of Relative Bioavailability of PPI-668 New Tablet Versus Capsule Formulations</brief_title>
  <official_title>A Phase 1, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of a New Tablet Formulation Versus the Current Capsule Formulation of PPI-668 in Healthy Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Presidio Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Presidio Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the blood levels of PPI-668 resulting from two different formulations&#xD;
      - the current capsule and a new tablet, T003.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PPI-668 area under the curve from time zero to infinity (AUC 0-inf)</measure>
    <time_frame>days 1-8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PPI-668 maximum observed plasma concentration (Cmax)</measure>
    <time_frame>Days 1-8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PPI-668 area under the curve from time zero to the last quantifiable concentration (AUC 0-t)</measure>
    <time_frame>Days 1-8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>assessments of adverse events</measure>
    <time_frame>days 1-8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assessments of composite of clinical laboratory parameters</measure>
    <time_frame>days 1-8</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Pharmacokinetic Assessments in Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>PPI-668 tablet followed by capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On day 1, one 200 mg PPI-668 tablet will be administered. On day 6, two 100 mg PI-668 capsules will be administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PPI-668 capsule followed by tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On day 1, two 100 mg PI-668 capsules will be administered. On day 6, one 200 mg PPI-668 tablet will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PPI-668 tablet</intervention_name>
    <arm_group_label>PPI-668 capsule followed by tablet</arm_group_label>
    <arm_group_label>PPI-668 tablet followed by capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PPI-668 capsule</intervention_name>
    <arm_group_label>PPI-668 capsule followed by tablet</arm_group_label>
    <arm_group_label>PPI-668 tablet followed by capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have the ability to understand and sign a written informed consent form&#xD;
&#xD;
          -  nonsmoker&#xD;
&#xD;
          -  body mass index (BMI) of 18.0 to 29.9 kg/m2 (inclusive)&#xD;
&#xD;
          -  HIV-1 antibody negative.&#xD;
&#xD;
          -  hepatitis B (HBV) surface antigen negative.&#xD;
&#xD;
          -  hepatitis C (HCV) antibody negative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating subjects.&#xD;
&#xD;
          -  Have any serious or active medical or psychiatric illness which, in the opinion of the&#xD;
             Investigator, would interfere with subject treatment, assessment, or compliance with&#xD;
             the protocol. This would include renal, cardiac, hematologic, hepatic, pulmonary&#xD;
             (including chronic asthma), endocrine (e.g., diabetes), central or peripheral nervous,&#xD;
             gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal&#xD;
             disease), or immunodeficiency disorders, active infection, or malignancy that is&#xD;
             clinically significant or requiring treatment.&#xD;
&#xD;
          -  Have participated in an investigational trial involving administration of any&#xD;
             investigational compound within 30 days prior to the study dosing.&#xD;
&#xD;
          -  Current alcohol or substance abuse judged by the Investigator to potentially interfere&#xD;
             with subject compliance.&#xD;
&#xD;
          -  Have poor venous access and unable to donate blood.&#xD;
&#xD;
          -  Have donated blood within 56 days of study dosing.&#xD;
&#xD;
          -  Have donated plasma within 7 days of study dosing.&#xD;
&#xD;
          -  Have taken any prescription medications or over-the-counter medications including&#xD;
             herbal products within 28 days of commencing study drug dosing with the exception of&#xD;
             vitamins and/or acetaminophen and/or ibuprofen and/or contraceptive medications.&#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>Nathaniel Brown, MD</last_name>
    <role>Study Director</role>
    <affiliation>Presidio Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Buffalo Clinical Research Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>January 20, 2015</last_update_submitted>
  <last_update_submitted_qc>January 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02258321
org study id: PPI-668-104
nct id: NCT02258321
lead sponsor: 
has dmc: No
This study will compare the blood levels of PPI-668 resulting from two different formulations
      - the current capsule and a new tablet, T003.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: PPI-668 area under the curve from time zero to infinity (AUC 0-inf)
time frame: days 1-8
measure: PPI-668 maximum observed plasma concentration (Cmax)
time frame: Days 1-8
measure: PPI-668 area under the curve from time zero to the last quantifiable concentration (AUC 0-t)
time frame: Days 1-8
measure: assessments of adverse events
time frame: days 1-8
measure: assessments of composite of clinical laboratory parameters
time frame: days 1-8
arm group label: PPI-668 tablet followed by capsule
arm group type: Experimental
description: On day 1, one 200 mg PPI-668 tablet will be administered. On day 6, two 100 mg PI-668 capsules will be administered.
arm group label: PPI-668 capsule followed by tablet
arm group type: Experimental
description: On day 1, two 100 mg PI-668 capsules will be administered. On day 6, one 200 mg PPI-668 tablet will be administered.
intervention type: Drug
intervention name: PPI-668 tablet
arm group label: PPI-668 capsule followed by tablet
arm group label: PPI-668 tablet followed by capsule
intervention type: Drug
intervention name: PPI-668 capsule
arm group label: PPI-668 capsule followed by tablet
arm group label: PPI-668 tablet followed by capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nathaniel Brown, MD
role: Study Director
affiliation: Presidio Pharmaceuticals
facility: 
country: United States
responsible party type: Sponsor