<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/NCT03010787</url>
  </required_header>
  <id_info>
    <org_study_id>V56501</org_study_id>
    <nct_id>NCT03010787</nct_id>
  </id_info>
  <brief_title>A First Time in Human Study in Healthy Volunteers and Patients</brief_title>
  <official_title>A Four Part, Phase 1, First Time in Human, Single Centre Study in Healthy Male Subjects, Patient Volunteers With Crohn's Disease and in Healthy Patient Volunteers With a Terminal Ileostomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VHsquared Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VHsquared Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multi-part study to investigate the safety, tolerability and local and systemic&#xD;
      pharmacokinetics of V565&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Parallel Assignment</intervention_model>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety &amp; tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECGs or vital signs</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of the concentrations of V565 in ileal fluid following a single dose</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pharmacokinetic parameter of V565: Cmax</measure>
    <time_frame>72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pharmacokinetic parameter of V565: AUC</measure>
    <time_frame>72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pharmacokinetic parameter of V565: tmax</measure>
    <time_frame>72 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Part 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single ascending dose of oral V565</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 - V565</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose level of oral V565 TID for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 and 2 - placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral placebo single dose (Part 1) or TID for 14 days (Part 2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of V565 in patient volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single ascending dose of V565 in patients with Crohn's Disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>V565</intervention_name>
    <description>single ascending dose of V565</description>
    <arm_group_label>Part 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>V565</intervention_name>
    <description>Multiple dose</description>
    <arm_group_label>Part 2 - V565</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Single and multiple dose</description>
    <arm_group_label>Part 1 and 2 - placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>V565</intervention_name>
    <description>Open-label single dose</description>
    <arm_group_label>Part 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>V565</intervention_name>
    <description>Open-label single ascending dose</description>
    <arm_group_label>Part 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parts 1 and 2&#xD;
&#xD;
               1. Adult male subjects aged 18 to 45 years inclusive.&#xD;
&#xD;
               2. Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive.&#xD;
&#xD;
               3. Body weight between 50.0 and 100.0 kg inclusive.&#xD;
&#xD;
               4. Subjects who are healthy as determined by pre study medical history, physical&#xD;
                  examination and 12-lead ECG, and clinical laboratory tests&#xD;
&#xD;
          -  Part 3&#xD;
&#xD;
               1. Adult male or female subjects aged 18 to 65 years.&#xD;
&#xD;
               2. Ileostomy for a minimum of 18 months for a non malignant disease indication.&#xD;
&#xD;
               3. A BMI between 18.0 and 32.0 kg/m2 inclusive.&#xD;
&#xD;
               4. Body weight between 50.0 and 100.0 kg inclusive.&#xD;
&#xD;
               5. Subjects who are healthy as determined by pre study medical history, physical&#xD;
                  examination and 12-lead ECG, and clinical laboratory tests&#xD;
&#xD;
          -  Part 4&#xD;
&#xD;
               1. Adult male or female subjects aged 18 to 65 years.&#xD;
&#xD;
               2. A confirmed diagnosis of Crohn's disease for a minimum of 6 months.&#xD;
&#xD;
               3. A BMI between 15.0 and 32.0 kg/m2 inclusive.&#xD;
&#xD;
               4. Subjects who have no other significant co-morbidity (other than those associated&#xD;
                  with Crohn's disease).&#xD;
&#xD;
               5. Subjects whose medical history, physical examination, clinical laboratory test&#xD;
                  results and 12-lead ECG have no clinically relevant abnormalities (other than&#xD;
                  those associated with Crohn's disease).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parts 1 and 2&#xD;
&#xD;
               1. A clinically significant abnormal medical history or clinically significant&#xD;
                  abnormal physical examination, including history of febrile illness within 1 week&#xD;
                  prior to the first dose.&#xD;
&#xD;
               2. A history of severe allergies, non-allergic drug reactions, or multiple drug&#xD;
                  allergies.&#xD;
&#xD;
               3. A known hypersensitivity to TNF inhibitors or any of the inactive ingredients of&#xD;
                  the study treatment.&#xD;
&#xD;
               4. A history of significant gastrointestinal (GI) disease, including GI motility&#xD;
                  disorders, GI malignancy or of polyposis coli.&#xD;
&#xD;
               5. Previous surgery to the GI tract with the exception of appendectomy.&#xD;
&#xD;
               6. A history of malignancy.&#xD;
&#xD;
               7. Any other condition which in the investigator's opinion will interfere with the&#xD;
                  trial or interpretation of the results.&#xD;
&#xD;
          -  Part 3&#xD;
&#xD;
               1. A history of Crohn's disease.&#xD;
&#xD;
               2. A clinically significant abnormal medical history (other than the condition&#xD;
                  leading to ileostomy) or clinically significant abnormal physical examination,&#xD;
                  including history of febrile illness within 1 week prior to the first dose.&#xD;
&#xD;
               3. A history of severe allergies, non-allergic drug reactions, or multiple drug&#xD;
                  allergies.&#xD;
&#xD;
               4. A known hypersensitivity or contraindication to TNF inhibitors or any of the&#xD;
                  inactive ingredients of the study treatment.&#xD;
&#xD;
               5. A known history of heart disease.&#xD;
&#xD;
               6. Any clinical evidence of active inflammatory bowel disease.&#xD;
&#xD;
               7. Any other condition which in the investigator's opinion will interfere with the&#xD;
                  trial or interpretation of the results.&#xD;
&#xD;
          -  Part 4&#xD;
&#xD;
               1. Subjects with severe Crohn's disease such as: those requiring surgery; those with&#xD;
                  a current abscess; those with a non inflammatory stricture; those with a history&#xD;
                  of obstruction.&#xD;
&#xD;
               2. Having ever received anti-TNF-α therapy or other biologics.&#xD;
&#xD;
               3. Required an increase in dose of either steroids or immunosuppressant therapy&#xD;
                  within the past 6 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suhail Nurbhai, MBChB</last_name>
    <role>Study Director</role>
    <affiliation>VHsquared Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quintiles Drug Research Unit at Guy's Hospital, Quintiles Ltd</name>
      <address>
        <city>London</city>
        <zip>SE1 1YR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_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/NCT03010787
org study id: V56501
nct id: NCT03010787
lead sponsor: 
has dmc: Yes
A multi-part study to investigate the safety, tolerability and local and systemic
      pharmacokinetics of V565
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECGs or vital signs
time frame: Up to 14 days
measure: Measurement of the concentrations of V565 in ileal fluid following a single dose
time frame: 24 hours
measure: Evaluation of pharmacokinetic parameter of V565: Cmax
time frame: 72 hours
measure: Evaluation of pharmacokinetic parameter of V565: AUC
time frame: 72 hours
measure: Evaluation of pharmacokinetic parameter of V565: tmax
time frame: 72 hours
arm group label: Part 1
arm group type: Experimental
description: Single ascending dose of oral V565
arm group label: Part 2 - V565
arm group type: Experimental
description: Single dose level of oral V565 TID for 14 days
arm group label: Part 1 and 2 - placebo
arm group type: Placebo Comparator
description: Oral placebo single dose (Part 1) or TID for 14 days (Part 2)
arm group label: Part 3
arm group type: Experimental
description: Single dose of V565 in patient volunteers
arm group label: Part 4
arm group type: Experimental
description: Single ascending dose of V565 in patients with Crohn's Disease
intervention type: Drug
intervention name: V565
description: single ascending dose of V565
arm group label: Part 1
intervention type: Drug
intervention name: V565
description: Multiple dose
arm group label: Part 2 - V565
intervention type: Drug
intervention name: Placebo
description: Single and multiple dose
arm group label: Part 1 and 2 - placebo
intervention type: Drug
intervention name: V565
description: Open-label single dose
arm group label: Part 3
intervention type: Drug
intervention name: V565
description: Open-label single ascending dose
arm group label: Part 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Suhail Nurbhai, MBChB
role: Study Director
affiliation: VHsquared Ltd.
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Crohn Disease
sharing ipd: No