<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/NCT03006367</url>
  </required_header>
  <id_info>
    <org_study_id>MDGN-NFC1-ADHD-101</org_study_id>
    <nct_id>NCT03006367</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic and Tolerability Study of NFC-1 in Subjects Aged 6-17 Years With ADHD</brief_title>
  <official_title>An Open-label, Single Ascending Dose, Pharmacokinetic and Tolerability Study of NFC-1 in Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aevi Genomic Medicine, LLC, a Cerecor company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Avalo Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a open-label, single ascending dose, pharmacokinetic, and tolerability study of NFC-1&#xD;
      in Children and Adolescents (Ages 6-17 Years) with ADHD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2017</start_date>
  <completion_date type="Actual">March 6, 2017</completion_date>
  <primary_completion_date type="Actual">February 26, 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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma drug concentration-time curve (AUC0-24h)</measure>
    <time_frame>24 hours of sample collections</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma drug concentration-time curve (AUC0-inf)</measure>
    <time_frame>28 hours of sample collections</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma drug concentration-time curve (AUClast)</measure>
    <time_frame>28 hours of sample collections</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal Half Life (T½ ) of NFC-1</measure>
    <time_frame>28 hours of sample collections</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>28 hours of sample collections</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>28 hours of sample collections</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent first order elimination rate constant (kel)</measure>
    <time_frame>28 hours of sample collections</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent oral clearance adjusted for bioavailability (CL/F) of NFC-1</measure>
    <time_frame>28 hours of sample collections</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution adjusted for bioavailability (Vz/F) of NFC-1</measure>
    <time_frame>28 hours of sample collections</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Attention Deficit Disorder With Hyperactivity</condition>
  <arm_group>
    <arm_group_label>NFC-1 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Dose of NFC-1 100 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NFC-1 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Dose of NFC-1 200 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NFC-1 400 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Dose of NFC-1 400 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NFC-1 800 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Dose of NFC-1 800 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NFC-1 100 mg</intervention_name>
    <arm_group_label>NFC-1 100 mg</arm_group_label>
    <other_name>AEVI-001</other_name>
    <other_name>MDGN-001</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NFC-1 200 mg</intervention_name>
    <arm_group_label>NFC-1 200 mg</arm_group_label>
    <other_name>AEVI-001</other_name>
    <other_name>MDGN-001</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NFC-1 400 mg</intervention_name>
    <arm_group_label>NFC-1 400 mg</arm_group_label>
    <other_name>AEVI-001</other_name>
    <other_name>MDGN-001</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NFC-1 800 mg</intervention_name>
    <arm_group_label>NFC-1 800 mg</arm_group_label>
    <other_name>AEVI-001</other_name>
    <other_name>MDGN-001</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject and parent/legally authorized representative (LAR) are able to speak English&#xD;
             fluently and have provided written informed consent, and assent (as applicable) for&#xD;
             this study.&#xD;
&#xD;
          2. Subject is 6 to 17 years inclusive at the time of consent/assent.&#xD;
&#xD;
          3. Subject is male, female of non-childbearing potential or non-pregnant, non-lactating&#xD;
             female of childbearing potential who agrees to comply with any applicable&#xD;
             contraceptive requirements 2 weeks prior to administration of IP and throughout the&#xD;
             study.&#xD;
&#xD;
          4. Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition&#xD;
             (DSM-5) criteria for a primary diagnosis of ADHD based on a M.I.N.I. International&#xD;
             Neuropsychiatric Interview.&#xD;
&#xD;
          5. Subject is considered &quot;healthy&quot;. Healthy status is defined by absence of evidence of&#xD;
             any active or chronic disease other than their ADHD following a detailed medical and&#xD;
             surgical history, a complete physical examination.&#xD;
&#xD;
          6. Subject has the ability to swallow a capsule of investigational product whole.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has a history of any hematological, hepatic, respiratory, cardiovascular,&#xD;
             renal, neurological, or psychiatric disease, gall bladder removal, or current or&#xD;
             recurrent disease other than their ADHD.&#xD;
&#xD;
          2. Subject has a current or relevant history of physical or psychiatric illness, or any&#xD;
             medical disorder that may require treatment.&#xD;
&#xD;
          3. Subject has a current, controlled or uncontrolled, comorbid psychiatric diagnosis with&#xD;
             significant symptoms.&#xD;
&#xD;
          4. Subject is considered a suicide risk in the opinion of the investigator, has&#xD;
             previously made a suicide attempt, or is currently demonstrating active suicidal&#xD;
             ideation.&#xD;
&#xD;
          5. Subject has used an investigational product, been enrolled in a clinical study&#xD;
             including vaccines, or had any changes in eating habits, within 30 days prior to the&#xD;
             first dose of investigational product.&#xD;
&#xD;
          6. Subject has a positive screen for alcohol or drugs of abuse, or a positive hepatitis B&#xD;
             surface antigen (HBsAg), hepatitis C virus (HCV), or HIV antibody screen.&#xD;
&#xD;
          7. Subject previously was an adolescent (12-17) who was either a screen failure, or&#xD;
             enrolled or participated in this study or another NFC1 clinical study.&#xD;
&#xD;
          8. Subject is currently taking any medication that might confound the results of safety&#xD;
             assessments conducted in the study.&#xD;
&#xD;
          9. Subject has a concurrent chronic or acute illness, disability, or other condition that&#xD;
             might confound the results of safety assessments conducted in the study.&#xD;
&#xD;
         10. Subject is unwilling to discontinue current ADHD medication to participate in the&#xD;
             study.&#xD;
&#xD;
         11. Subject has a clinical laboratory abnormality that indicates clinically significant&#xD;
             hematologic, hepatobiliary, or renal disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Meridien Research, Inc.</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QPS-MRA, LLC (Miami Research Associates)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Psychiatry and Behavioral Medicine</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>July 2, 2021</last_update_submitted>
  <last_update_submitted_qc>July 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2021</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>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03006367
org study id: MDGN-NFC1-ADHD-101
nct id: NCT03006367
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a open-label, single ascending dose, pharmacokinetic, and tolerability study of NFC-1
      in Children and Adolescents (Ages 6-17 Years) with ADHD.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the plasma drug concentration-time curve (AUC0-24h)
time frame: 24 hours of sample collections
measure: Area under the plasma drug concentration-time curve (AUC0-inf)
time frame: 28 hours of sample collections
measure: Area under the plasma drug concentration-time curve (AUClast)
time frame: 28 hours of sample collections
measure: Terminal Half Life (T½ ) of NFC-1
time frame: 28 hours of sample collections
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: 28 hours of sample collections
measure: Time to Maximum Observed Plasma Concentration (Tmax)
time frame: 28 hours of sample collections
measure: Apparent first order elimination rate constant (kel)
time frame: 28 hours of sample collections
measure: Apparent oral clearance adjusted for bioavailability (CL/F) of NFC-1
time frame: 28 hours of sample collections
measure: Apparent volume of distribution adjusted for bioavailability (Vz/F) of NFC-1
time frame: 28 hours of sample collections
arm group label: NFC-1 100 mg
arm group type: Experimental
description: Single Dose of NFC-1 100 mg
arm group label: NFC-1 200 mg
arm group type: Experimental
description: Single Dose of NFC-1 200 mg
arm group label: NFC-1 400 mg
arm group type: Experimental
description: Single Dose of NFC-1 400 mg
arm group label: NFC-1 800 mg
arm group type: Experimental
description: Single Dose of NFC-1 800 mg
intervention type: Drug
intervention name: NFC-1 100 mg
arm group label: NFC-1 100 mg
other name: AEVI-001
other name: MDGN-001
intervention type: Drug
intervention name: NFC-1 200 mg
arm group label: NFC-1 200 mg
other name: AEVI-001
other name: MDGN-001
intervention type: Drug
intervention name: NFC-1 400 mg
arm group label: NFC-1 400 mg
other name: AEVI-001
other name: MDGN-001
intervention type: Drug
intervention name: NFC-1 800 mg
arm group label: NFC-1 800 mg
other name: AEVI-001
other name: MDGN-001
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: Undecided