<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/NCT03817346</url>
  </required_header>
  <id_info>
    <org_study_id>GAB-001</org_study_id>
    <nct_id>NCT03817346</nct_id>
  </id_info>
  <brief_title>Study of Ascending Single Oral Dose of GT-002 in Healthy Volunteers</brief_title>
  <acronym>GAB-001</acronym>
  <official_title>A Phase I, Randomised, Double-blind, Placebo-controlled Study in Healthy Male Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Ascending Single Oral Doses of GT-002</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gabather AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Smerud Medical Research International AS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gabather AB</source>
  <oversight_info>
    <has_dmc>Yes</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 study does not target any disease or condition in itself, but is evaluating the safety,&#xD;
      tolerability and pharmacokinetics of single oral doses of GT-002 in the setting of healthy&#xD;
      volunteers.&#xD;
&#xD;
      A longer-term objective is to apply the findings from this study to design and later conduct&#xD;
      a clinical development programme of GT-002 as a medication to treat schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</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>
    <intervention_model_description>Single ascending dose</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Double blinde</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events (AEs)</measure>
    <time_frame>Day 1 to day 3</time_frame>
    <description>To evaluate the safety and tolerability GT-002 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter AUCt</measure>
    <time_frame>Day1 to day 3</time_frame>
    <description>Area under the curve from the time of dosing until the last quantifiable concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter AUC0-24</measure>
    <time_frame>Day1 to day 2</time_frame>
    <description>Area under the curve from the time of dosing until 24 hours post dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter AUC0-infinity</measure>
    <time_frame>day 1 to day 3</time_frame>
    <description>Area under the curve from the time of dosing extrapolated to infinity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter Cmax</measure>
    <time_frame>Day 1 to day 3</time_frame>
    <description>Maximum concentration (Cmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax</measure>
    <time_frame>Day 1 to day 3</time_frame>
    <description>Time to maximum concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2</measure>
    <time_frame>Day 1 to day 3</time_frame>
    <description>Apparent terminal elimination half-life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Safety and Tolerability</condition>
  <arm_group>
    <arm_group_label>Experimental GT-002 SAD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy volunteers meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 7 dose ascending cohorts) to receive either GT-002 or placebo. The study drug (GT-002 or placebo) will be administered orally as a single dose. Six of out 8 subjects per cohort will be randomized to receive GT-002.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Placebo oral capsule SAD</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Healthy volunteers meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 7 dose ascending cohorts) to receive either GT-002 or placebo. The study drug (GT-002 or placebo) will be administered orally as a single dose. Two of out 8 subjects per cohort will be randomized to receive GT-002.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GT-002</intervention_name>
    <description>Single ascending dose</description>
    <arm_group_label>Experimental GT-002 SAD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Comparator single ascending dose</description>
    <arm_group_label>Experimental Placebo oral capsule SAD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is willing and able to give written informed consent for participation in the&#xD;
             study. Sufficient command of the Finnish language will be needed for informed consent&#xD;
             and adequate communication with the study personnel.&#xD;
&#xD;
          2. Healthy male subjects from 18 up to 45 years of age.&#xD;
&#xD;
          3. Body mass index (BMI) from 18 kg/m2 up to 28 kg/m2.&#xD;
&#xD;
          4. Body weight from 60 kg up to 120 kg.&#xD;
&#xD;
          5. Clinically normal medical history, physical findings, vital signs, ECG and laboratory&#xD;
             values as judged by the investigator at the time of the screening visit. A subject&#xD;
             with a clinical abnormality or laboratory parameters outside of the reference range&#xD;
             for the population being studied may be included at the investigator´s discretion&#xD;
             provided the finding is unlikely to introduce additional risk factors, jeopardize&#xD;
             study integrity, or to interfere with the study assessments or procedures.&#xD;
&#xD;
          6. Subjects must be willing to use condom or other contraceptive methods with a failure&#xD;
             rate of &lt; 1% and refrain from donating sperm from the date of dosing until one month&#xD;
             after last dosing.&#xD;
&#xD;
             -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current or history of any clinically significant disease or disorder which, in the&#xD;
             opinion of the investigator, may either put the subject at risk because of&#xD;
             participation in the study, or influence the results or the subject's ability to&#xD;
             participate in the study&#xD;
&#xD;
          2. History of any type of cancer.&#xD;
&#xD;
          3. Subjects considered unlikely to comply with study procedures, restrictions and&#xD;
             requirements&#xD;
&#xD;
          4. Any clinically significant illness, medical/surgical procedure or trauma within 4&#xD;
             weeks of the administration of investigational product that is likely to introduce&#xD;
             additional risk factors, jeopardize study integrity, or to interfere with the study&#xD;
             assessments or procedures&#xD;
&#xD;
          5. Any clinically significant abnormalities in clinical chemistry, haematology,&#xD;
             coagulation or urinalysis results at the time of screening visit as judged by the&#xD;
             investigator&#xD;
&#xD;
          6. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C&#xD;
             antibody or human immunodeficiency virus (HIV)&#xD;
&#xD;
          7. After 10 minutes of supine rest, abnormal vital signs defined as any of the following:&#xD;
&#xD;
               1. Systolic blood pressure &gt; 140 mm Hg (average of two measurements)&#xD;
&#xD;
               2. Diastolic blood pressure &gt; 90 mm Hg (average of two measurements)&#xD;
&#xD;
               3. Heart rate &lt; 40 or &gt; 85 beats per minute (average of two measurements)&#xD;
&#xD;
               4. Body temperature (auricular) ≥38oC&#xD;
&#xD;
          8. Prolonged QTcF interval (&gt;450 ms), clinically significant cardiac arrhythmia or any&#xD;
             other clinically significant abnormalities in the resting ECG as judged by the&#xD;
             investigator&#xD;
&#xD;
          9. Intake of any medication, vitamin or mineral supplement product that could affect the&#xD;
             outcome of the study, within 2 weeks prior to the first study treatment administration&#xD;
             or less than 5 times the half-life of the medication. Possible prior use of enzyme&#xD;
             inducing drugs will be considered case-by-case by the investigator.&#xD;
&#xD;
         10. Any blood donation/blood loss &gt; 250 ml during the 3 months prior to screening&#xD;
&#xD;
         11. Has received another new chemical entity (defined as a compound which has not been&#xD;
             approved for marketing) or has participated in any other clinical trial that included&#xD;
             drug treatment within 3 months of the administration of investigational product in&#xD;
             this study. Subjects consented and screened but not dosed in previous phase I studies&#xD;
             can be included in this study.&#xD;
&#xD;
         12. Current or history of alcohol or drug abuse within the last 5 years, current excessive&#xD;
             use of alcohol (current regular alcohol drinking of more than 24 units/week) or use of&#xD;
             illicit drugs.&#xD;
&#xD;
         13. Positive screen for drugs of abuse at screening or on admission to the unit or&#xD;
             positive breath test result for alcohol at screening or on admission to the unit prior&#xD;
             to the administration of investigational product.&#xD;
&#xD;
         14. Known allergy to the components used in the formulation of GT-002.&#xD;
&#xD;
         15. Current smokers or users of nicotine products. Irregular use of nicotine (e.g.&#xD;
             smoking, snuffing, and chewing tobacco) up to five doses per week is allowed before&#xD;
             screening visit.&#xD;
&#xD;
         16. Intake of &gt;5 cups of coffee/day or the corresponding amount of other caffeine&#xD;
             containing beverages (e.g. energy drinks containing caffeine) during the study.&#xD;
&#xD;
         17. Subjects who have planned any scheduled invasive treatment or medical/surgical&#xD;
             procedure during the study period.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Male</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yvonne Peltonen</last_name>
    <role>Study Chair</role>
    <affiliation>Smerud Medical Research Finland Ab/Oy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CRST Oy, Clinical Research Services Turku</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Safety</keyword>
  <keyword>Tolerability</keyword>
  <keyword>Pharmacokinetics</keyword>
  <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/NCT03817346
org study id: GAB-001
nct id: NCT03817346
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study does not target any disease or condition in itself, but is evaluating the safety,
      tolerability and pharmacokinetics of single oral doses of GT-002 in the setting of healthy
      volunteers.

      A longer-term objective is to apply the findings from this study to design and later conduct
      a clinical development programme of GT-002 as a medication to treat schizophrenia.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single ascending dose
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
masking description: Double blinde
measure: Adverse Events (AEs)
time frame: Day 1 to day 3
description: To evaluate the safety and tolerability GT-002 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs
measure: Pharmacokinetic parameter AUCt
time frame: Day1 to day 3
description: Area under the curve from the time of dosing until the last quantifiable concentration
measure: Pharmacokinetic parameter AUC0-24
time frame: Day1 to day 2
description: Area under the curve from the time of dosing until 24 hours post dosing
measure: Pharmacokinetic parameter AUC0-infinity
time frame: day 1 to day 3
description: Area under the curve from the time of dosing extrapolated to infinity
measure: Pharmacokinetic parameter Cmax
time frame: Day 1 to day 3
description: Maximum concentration (Cmax)
measure: tmax
time frame: Day 1 to day 3
description: Time to maximum concentration
measure: t1/2
time frame: Day 1 to day 3
description: Apparent terminal elimination half-life
arm group label: Experimental GT-002 SAD
arm group type: Active Comparator
description: Healthy volunteers meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 7 dose ascending cohorts) to receive either GT-002 or placebo. The study drug (GT-002 or placebo) will be administered orally as a single dose. Six of out 8 subjects per cohort will be randomized to receive GT-002.
arm group label: Experimental Placebo oral capsule SAD
arm group type: Placebo Comparator
description: Healthy volunteers meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 7 dose ascending cohorts) to receive either GT-002 or placebo. The study drug (GT-002 or placebo) will be administered orally as a single dose. Two of out 8 subjects per cohort will be randomized to receive GT-002.
intervention type: Drug
intervention name: GT-002
description: Single ascending dose
arm group label: Experimental GT-002 SAD
intervention type: Drug
intervention name: Placebo oral capsule
description: Comparator single ascending dose
arm group label: Experimental Placebo oral capsule SAD
criteria: 
gender: Male
gender based: Yes
gender description: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yvonne Peltonen
role: Study Chair
affiliation: Smerud Medical Research Finland Ab/Oy
facility: 
country: Finland
responsible party type: Sponsor
sharing ipd: No