<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/NCT02254369</url>
  </required_header>
  <id_info>
    <org_study_id>GC-100-01</org_study_id>
    <nct_id>NCT02254369</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Doses of GC021109 in Healthy Subjects</brief_title>
  <official_title>A Randomized, Phase 1, Double-Blind, Placebo-Controlled, First-in-Human, Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Doses of GC021109 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GliaCure, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GliaCure, Inc.</source>
  <brief_summary>
    <textblock>
      The primary objective of the study is to assess the safety and tolerability of single oral&#xD;
      doses of GC021109 when administered to healthy adult subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number and severity of TEAEs</measure>
    <time_frame>following single dosage</time_frame>
  </primary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Cohort 1- GC021109</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose, 0.0014 mg/kg GC021109</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2- GC021109</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose, 0.014 mg/kg GC021109</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3-GC021109</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose, 0.14 mg/kg GC021109</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4- GC021109</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose, 1.4 mg/kg GC021109 subjects will receive GC021109 under fasting then under fed conditions separated by a washout of 14 (± 1) days after the first dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5- GC021109</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose, 4.2 mg/kg GC021109</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1- placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>single dose, 0.0014 mg/kg matching placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2- placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>single dose, 0.014 mg/kg matching placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3- placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>single dose, 0.14 mg/kg matching placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4- placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>single dose, 1.4 mg/kg subjects will receive matching placebo under fasting then under fed conditions separated by a washout of 14 (+/- 1) days after the first dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5- placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>single dose, 4.2 mg/kg matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GC021109</intervention_name>
    <arm_group_label>Cohort 1- GC021109</arm_group_label>
    <arm_group_label>Cohort 2- GC021109</arm_group_label>
    <arm_group_label>Cohort 3-GC021109</arm_group_label>
    <arm_group_label>Cohort 4- GC021109</arm_group_label>
    <arm_group_label>Cohort 5- GC021109</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Cohort 1- placebo</arm_group_label>
    <arm_group_label>Cohort 2- placebo</arm_group_label>
    <arm_group_label>Cohort 3- placebo</arm_group_label>
    <arm_group_label>Cohort 4- placebo</arm_group_label>
    <arm_group_label>Cohort 5- placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adult male and/or non-childbearing potential females, 18 to 55 years of age,&#xD;
             inclusive, at the time of informed consent.&#xD;
&#xD;
          2. Continuous non-smoker who has not used nicotine-containing products for at least 3&#xD;
             months prior to dosing of study drug.&#xD;
&#xD;
          3. BMI ≥ 18.5 and ≤ 32.0 (kg/m2) at screening with a maximum weight of 120 kg.&#xD;
&#xD;
          4. Medically healthy with no clinically significant screening results that would exclude&#xD;
             subject from the study as deemed by the PI.&#xD;
&#xD;
          5. Females must have undergone 1 of the following sterilization procedures, and have&#xD;
             official documentation, at least 6 months prior to dosing of study drug:&#xD;
&#xD;
               -  Hysteroscopic sterilization&#xD;
&#xD;
               -  Bilateral tubal ligation or bilateral salpingectomy&#xD;
&#xD;
               -  Hysterectomy.&#xD;
&#xD;
               -  Bilateral oophorectomy. OR be postmenopausal with amenorrhea for at least 1 year&#xD;
                  prior to dosing of study drug and have follicle-stimulating hormone (FSH) serum&#xD;
                  levels consistent with postmenopausal status.&#xD;
&#xD;
          6. All male subjects must agree to use a condom with spermicide or abstain from sexual&#xD;
             intercourse during the study until 90 days beyond the last dose of study drug.&#xD;
&#xD;
          7. If male, must agree to not donate sperm from Day -1 until 90 days after dosing.&#xD;
&#xD;
          8. Understand the study procedures in the ICF, and be willing and able to comply with the&#xD;
             protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is mentally or legally incapacitated or has significant emotional problems at&#xD;
             the time of screening visit or expected during the conduct of the study.&#xD;
&#xD;
          2. History or presence of clinically significant medical or psychiatric condition or&#xD;
             disease in the opinion of the PI.&#xD;
&#xD;
          3. History of any illness that, in the opinion of the PI, might confound the results of&#xD;
             the study or pose an additional risk to the subject by their participation in the&#xD;
             study.&#xD;
&#xD;
          4. History or presence of alcoholism or drug abuse within the past 2 years prior to&#xD;
             screening.&#xD;
&#xD;
          5. History or presence of hypersensitivity or idiosyncratic reaction to component of the&#xD;
             study drug or related compounds.&#xD;
&#xD;
          6. History of cancer within the past 5 years (excluding non-melanoma skin cancer) prior&#xD;
             to screening.&#xD;
&#xD;
          7. Clinically significant abnormal screening laboratory test values (as determined by the&#xD;
&#xD;
             PI), including, but not limited to, the following:&#xD;
&#xD;
               -  any values for alanine aminotransferase (ALT) or aspartate aminotransferase (AST)&#xD;
                  that are above the upper limit of the reference range at screening or check-in.&#xD;
&#xD;
               -  any values for total or direct bilirubin that are 1.5 times above the upper limit&#xD;
                  of the reference range at screening or check-in.&#xD;
&#xD;
               -  estimated creatinine clearance &lt;90 mL/min at screening only.&#xD;
&#xD;
          8. Clinically significant infection within 3 months prior to screening as determined by&#xD;
             the PI.&#xD;
&#xD;
          9. Female subjects of child-bearing potential.&#xD;
&#xD;
         10. Female subjects who are pregnant or lactating.&#xD;
&#xD;
         11. Positive urine drug or urine alcohol results at screening or check-in.&#xD;
&#xD;
         12. Positive urine cotinine at screening.&#xD;
&#xD;
         13. Positive results at screening for HIV, hepatitis B surface antigen (HBsAg), or&#xD;
             hepatitis C virus (HCV).&#xD;
&#xD;
         14. Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at&#xD;
             screening.&#xD;
&#xD;
         15. Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.&#xD;
&#xD;
         16. Orthostatic vital sign results as deemed clinically significant in the opinion of the&#xD;
             PI at screening.&#xD;
&#xD;
         17. QTcB interval is &gt;430 msec (males) or &gt;450 msec (females) or deemed clinically&#xD;
             abnormal by the PI, prior to dosing of study drug.&#xD;
&#xD;
         18. Unable to refrain from or anticipates the use of:&#xD;
&#xD;
               -  Any drug, including prescription and non-prescription medications, herbal&#xD;
                  remedies, vitamin supplements or substrates of CYP1A2, CYP3B6, or CYP3A4&#xD;
                  beginning 14 days prior to dosing of study drug and throughout the study.&#xD;
                  Acetaminophen (up to 2 g per 24 hour period) may be permitted during the study.&#xD;
&#xD;
               -  Any drugs known to be significant inducers of CYP enzymes and/or P-glycoprotein&#xD;
                  (P-gp), including St. John's Wort, for 28 days prior to dosing of study drug and&#xD;
                  throughout the study. Appropriate sources will be consulted by the PI or designee&#xD;
                  to confirm lack of PK/PD interaction with study drug.&#xD;
&#xD;
         19. Has been on a diet incompatible with the on-study diet, in the opinion of the PI,&#xD;
             within the 28 days prior to dosing of study drug, and throughout the study.&#xD;
&#xD;
         20. Has donated blood within 3 months of screening visit or plans to donate blood within 3&#xD;
             months of study completion, except for blood collected during another clinical trial&#xD;
             performed 30 days prior to screening.&#xD;
&#xD;
         21. Plasma donation within 7 days prior to dosing of study drug.&#xD;
&#xD;
         22. Participation in another clinical trial within 30 days prior to screening. The 30-day&#xD;
             window will be derived from the date of the last study scheduled blood collection or&#xD;
             dosing, whichever is later, in the previous study to the date of screening for the&#xD;
             current study.&#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>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>07753</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>February 17, 2015</last_update_submitted>
  <last_update_submitted_qc>February 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 18, 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/NCT02254369
org study id: GC-100-01
nct id: NCT02254369
lead sponsor: 
The primary objective of the study is to assess the safety and tolerability of single oral
      doses of GC021109 when administered to healthy adult subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number and severity of TEAEs
time frame: following single dosage
arm group label: Cohort 1- GC021109
arm group type: Experimental
description: single dose, 0.0014 mg/kg GC021109
arm group label: Cohort 2- GC021109
arm group type: Experimental
description: single dose, 0.014 mg/kg GC021109
arm group label: Cohort 3-GC021109
arm group type: Experimental
description: single dose, 0.14 mg/kg GC021109
arm group label: Cohort 4- GC021109
arm group type: Experimental
description: single dose, 1.4 mg/kg GC021109 subjects will receive GC021109 under fasting then under fed conditions separated by a washout of 14 (± 1) days after the first dose.
arm group label: Cohort 5- GC021109
arm group type: Experimental
description: single dose, 4.2 mg/kg GC021109
arm group label: Cohort 1- placebo
arm group type: Placebo Comparator
description: single dose, 0.0014 mg/kg matching placebo
arm group label: Cohort 2- placebo
arm group type: Placebo Comparator
description: single dose, 0.014 mg/kg matching placebo
arm group label: Cohort 3- placebo
arm group type: Placebo Comparator
description: single dose, 0.14 mg/kg matching placebo
arm group label: Cohort 4- placebo
arm group type: Placebo Comparator
description: single dose, 1.4 mg/kg subjects will receive matching placebo under fasting then under fed conditions separated by a washout of 14 (+/- 1) days after the first dose.
arm group label: Cohort 5- placebo
arm group type: Placebo Comparator
description: single dose, 4.2 mg/kg matching placebo
intervention type: Drug
intervention name: GC021109
arm group label: Cohort 1- GC021109
arm group label: Cohort 2- GC021109
arm group label: Cohort 3-GC021109
arm group label: Cohort 4- GC021109
arm group label: Cohort 5- GC021109
intervention type: Other
intervention name: Placebo
arm group label: Cohort 1- placebo
arm group label: Cohort 2- placebo
arm group label: Cohort 3- placebo
arm group label: Cohort 4- placebo
arm group label: Cohort 5- placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor