<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/NCT03836222</url>
  </required_header>
  <id_info>
    <org_study_id>PCS499.1005</org_study_id>
    <nct_id>NCT03836222</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy Subjects</brief_title>
  <official_title>A Phase I, Single Centre, Open-Label, Non-Randomised Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® (Pentoxifylline) Administered to Healthy Subjects Under Fed Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Processa Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quotient Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Processa Pharmaceuticals</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a Phase I, single centre, open-label, non-randomised study and was designed to be&#xD;
      conducted in up to 2 parts. The purpose of Part 1 was to identify a MR formulation of PCS499&#xD;
      that would provide an optimal dosing regimen in patients. The purpose of Part 2 of the study&#xD;
      was to generate repeat dose information for the selected MR formulation of PCS499 in order to&#xD;
      provide additional PK information for future patient studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2018</start_date>
  <completion_date type="Actual">June 4, 2018</completion_date>
  <primary_completion_date type="Actual">June 4, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum plasma concentrations (Cmax) for Part 1</measure>
    <time_frame>Blood samples will be drawn prior to single dose administration of study drug and at 11 other timepoints in a 24 hour period.</time_frame>
    <description>Serial blood sampling at specified time points for determination of plasma concentration-time profiles</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum plasma concentrations (Cmax) in Part 2</measure>
    <time_frame>Blood sampling will be drawn prior to the single dose administration on Days 1 &amp; 4 and at 11 other timepoints in the following 24 hours. In addition, pre-dose trough samples will be taken on Days 2 &amp;3.</time_frame>
    <description>Serial blood sampling at specified time points for determination of plasma concentration-time profiles</description>
  </primary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>PCS499 MR Tablet Prototype 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>600 mg single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trental MR tablet 400mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCS499 MR Tablet Prototype 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>600mg single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCS499 MR Tablet Prototype 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>600mg single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trental MR Tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>400 mg multiple dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCS499 MR Tablet 900mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>multiple dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCS499 MR Tablet 600mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>multiple dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PCS499</intervention_name>
    <description>MR tablet</description>
    <arm_group_label>PCS499 MR Tablet 600mg</arm_group_label>
    <arm_group_label>PCS499 MR Tablet 900mg</arm_group_label>
    <arm_group_label>PCS499 MR Tablet Prototype 1</arm_group_label>
    <arm_group_label>PCS499 MR Tablet Prototype 2</arm_group_label>
    <arm_group_label>PCS499 MR Tablet Prototype 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trental</intervention_name>
    <description>comparator tablet</description>
    <arm_group_label>Trental MR Tablet</arm_group_label>
    <arm_group_label>Trental MR tablet 400mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or non-pregnant, non-lactating female subjects&#xD;
&#xD;
          2. Aged 18 to 55 years, inclusive&#xD;
&#xD;
          3. Subjects who were healthy as determined by no clinically relevant abnormalities&#xD;
             identified by a detailed medical history, full physical examination, vital signs,&#xD;
             12-lead resting electrocardiogram (ECG; corrected QT interval [QTc] ≤450, QRS &lt;120, PR&#xD;
             &lt;220; normal morphology) performed at the screening visit and prior to each dosing&#xD;
&#xD;
          4. Body mass index (BMI) of 18.0 to 35.0 kg/m2 inclusive or, if outside the range,&#xD;
             considered not clinically significant by the investigator and body weight &gt;50 kg&#xD;
&#xD;
          5. Subjects who were willing and able to be confined at the clinical research centre for&#xD;
             the scheduled inpatient visits&#xD;
&#xD;
          6. Ability to swallow multiple tablets whole&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject had a clinically significant history of GI, cardiovascular, musculoskeletal,&#xD;
             endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic,&#xD;
             immunologic, and/or lipid metabolism disorders and/or drug hypersensitivity&#xD;
&#xD;
          2. Subject had a known or suspected malignancy with the exception of basal cell carcinoma&#xD;
&#xD;
          3. Subject had a positive blood screen for human immunodeficiency virus (HIV), hepatitis&#xD;
             B surface antigen (HBsAg), or hepatitis C virus antibody (HCV Ab) at the screening&#xD;
             visit&#xD;
&#xD;
          4. Female subjects who were pregnant or lactating (all female subjects required a&#xD;
             negative serum pregnancy test at the screening and a negative urine pregnancy test at&#xD;
             each admission).&#xD;
&#xD;
          5. Subject had active disease or symptoms within 7 days prior to Day -1, such as nausea,&#xD;
             vomiting, diarrhoea, and infection&#xD;
&#xD;
          6. Subject had undergone a hospital admission or major surgery within 30 days prior to&#xD;
             the Screening visit&#xD;
&#xD;
          7. Subjects who had taken part in Part 1 were not permitted to take part in Part 2&#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>Sharan Sidhu, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quotient Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Sciences</name>
      <address>
        <city>Ruddington</city>
        <state>Nottingham</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</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>Pentoxifylline</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/NCT03836222
org study id: PCS499.1005
nct id: NCT03836222
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This was a Phase I, single centre, open-label, non-randomised study and was designed to be
      conducted in up to 2 parts. The purpose of Part 1 was to identify a MR formulation of PCS499
      that would provide an optimal dosing regimen in patients. The purpose of Part 2 of the study
      was to generate repeat dose information for the selected MR formulation of PCS499 in order to
      provide additional PK information for future patient studies.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Maximum plasma concentrations (Cmax) for Part 1
time frame: Blood samples will be drawn prior to single dose administration of study drug and at 11 other timepoints in a 24 hour period.
description: Serial blood sampling at specified time points for determination of plasma concentration-time profiles
measure: Maximum plasma concentrations (Cmax) in Part 2
time frame: Blood sampling will be drawn prior to the single dose administration on Days 1 & 4 and at 11 other timepoints in the following 24 hours. In addition, pre-dose trough samples will be taken on Days 2 &3.
description: Serial blood sampling at specified time points for determination of plasma concentration-time profiles
arm group label: PCS499 MR Tablet Prototype 2
arm group type: Experimental
description: 600 mg single dose
arm group label: Trental MR tablet 400mg
arm group type: Active Comparator
description: single dose
arm group label: PCS499 MR Tablet Prototype 4
arm group type: Experimental
description: 600mg single dose
arm group label: PCS499 MR Tablet Prototype 1
arm group type: Experimental
description: 600mg single dose
arm group label: Trental MR Tablet
arm group type: Active Comparator
description: 400 mg multiple dose
arm group label: PCS499 MR Tablet 900mg
arm group type: Experimental
description: multiple dose
arm group label: PCS499 MR Tablet 600mg
arm group type: Experimental
description: multiple dose
intervention type: Drug
intervention name: PCS499
description: MR tablet
arm group label: PCS499 MR Tablet 600mg
arm group label: PCS499 MR Tablet 900mg
arm group label: PCS499 MR Tablet Prototype 1
arm group label: PCS499 MR Tablet Prototype 2
arm group label: PCS499 MR Tablet Prototype 4
intervention type: Drug
intervention name: Trental
description: comparator tablet
arm group label: Trental MR Tablet
arm group label: Trental MR tablet 400mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sharan Sidhu, MBChB
role: Principal Investigator
affiliation: Quotient Sciences
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Pentoxifylline
sharing ipd: No