<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/NCT03031574</url>
  </required_header>
  <id_info>
    <org_study_id>CTP1S240105HT4</org_study_id>
    <nct_id>NCT03031574</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-D4010 in Healthy Subjects</brief_title>
  <official_title>A Phase 1, Single-Center, Single-Dose, 2-Way Crossover, Randomized Food-Effect and Non-Randomized Gender- and Age- Effect Pharmacokinetic Study of SUVN-D4010 Orally Administered in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suven Life Sciences Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Suven Life Sciences Limited</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of the study is to evaluate the effect of food, gender, and age on the&#xD;
      single-dose pharmacokinetics (PK) of SUVN-D4010.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of the study is to evaluate the safety and tolerability of orally&#xD;
      administered SUVN-D4010 under single-dose conditions in healthy adult male and female&#xD;
      subjects and healthy elderly male subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2017</start_date>
  <completion_date type="Actual">September 7, 2017</completion_date>
  <primary_completion_date type="Actual">August 29, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under concentration (AUC)</measure>
    <time_frame>72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed concentration (Cmax)</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Cognitive Disorder</condition>
  <arm_group>
    <arm_group_label>Food Effect</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SUVN-D4010 tablets single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gender Effect</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SUVN-D4010 tablets single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Age Effect</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SUVN-D4010 tablets single dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SUVN-D4010</intervention_name>
    <description>Tablets</description>
    <arm_group_label>Age Effect</arm_group_label>
    <arm_group_label>Food Effect</arm_group_label>
    <arm_group_label>Gender Effect</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects, aged 18 to 45 years, inclusive; healthy female subjects, aged&#xD;
             18 to 45 years, inclusive; healthy elderly male subjects, aged ≥65 years.&#xD;
&#xD;
          -  Have a body mass index (BMI) between 18.0 and 30.0kg/m2 (inclusive) and weigh at least&#xD;
             50 kg and no more than 100 kg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of gastrointestinal, hepatic, or renal disease, or any other&#xD;
             condition known to interfere with absorption, distribution, metabolism, or excretion&#xD;
             of drugs.&#xD;
&#xD;
          -  Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks&#xD;
             of the (first) administration of the study drug.&#xD;
&#xD;
          -  Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C&#xD;
             virus antibody, and human immunodeficiency virus antibody.&#xD;
&#xD;
          -  Plasma or blood product donation within 1 month of the (first) administration of the&#xD;
             study drug and any blood donation/blood loss more than 500 mL within the 2 months&#xD;
             prior to the (first) administration of the study drug.&#xD;
&#xD;
          -  As judged by the Investigator that the subject should not participate in the study if&#xD;
             he/she is considered unlikely to comply with study procedures, restrictions, and&#xD;
             requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Dickerson, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>PRA Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PRA Health Sciences</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>September 21, 2017</last_update_submitted>
  <last_update_submitted_qc>September 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Serotonin 4 (5-HT4) receptor</keyword>
  <keyword>Phase 1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
    <mesh_term>Cognition Disorders</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/NCT03031574
org study id: CTP1S240105HT4
nct id: NCT03031574
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study is to evaluate the effect of food, gender, and age on the
      single-dose pharmacokinetics (PK) of SUVN-D4010.
The main objective of the study is to evaluate the safety and tolerability of orally
      administered SUVN-D4010 under single-dose conditions in healthy adult male and female
      subjects and healthy elderly male subjects.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under concentration (AUC)
time frame: 72 hours
measure: Maximum observed concentration (Cmax)
time frame: Day 1
arm group label: Food Effect
arm group type: Active Comparator
description: SUVN-D4010 tablets single dose
arm group label: Gender Effect
arm group type: Active Comparator
description: SUVN-D4010 tablets single dose
arm group label: Age Effect
arm group type: Active Comparator
description: SUVN-D4010 tablets single dose
intervention type: Drug
intervention name: SUVN-D4010
description: Tablets
arm group label: Age Effect
arm group label: Food Effect
arm group label: Gender Effect
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Dickerson, MD, PhD
role: Principal Investigator
affiliation: PRA Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
mesh term: Cognition Disorders
sharing ipd: No