<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/NCT03792971</url>
  </required_header>
  <id_info>
    <org_study_id>GTI-4419-005</org_study_id>
    <nct_id>NCT03792971</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects</brief_title>
  <official_title>Phase 1, Open-label, One-arm, Fixed-sequence Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galera Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galera Therapeutics, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a single center, phase 1, open-label, fixed-sequence study under fasting&#xD;
      conditions to evaluate the effect of 90 mg intravenous (IV) infusions of GC4419 on the&#xD;
      single-dose pharmacokinetic (PK) of dextromethorphan (DM) capsules liquid filled.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2019</start_date>
  <completion_date type="Actual">February 15, 2019</completion_date>
  <primary_completion_date type="Actual">February 15, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-t</measure>
    <time_frame>Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-inf</measure>
    <time_frame>Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): Cmax</measure>
    <time_frame>Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Fixed Sequence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dextromethorphan HBr</intervention_name>
    <description>A single 60 mg dose of DM capsules liquid-filled on Day 1 and Day 3</description>
    <arm_group_label>Fixed Sequence</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GC4419</intervention_name>
    <description>Daily 90 mg IV infusions over 60 minutes on Day 3 and Day 4</description>
    <arm_group_label>Fixed Sequence</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, non-smoker, ≥ 18 and ≤ 55 years of age, with BMI &gt; 18.5 and &lt; 30.0&#xD;
             kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.&#xD;
&#xD;
          2. Healthy as defined by:&#xD;
&#xD;
               1. the absence of clinically significant illness and surgery within 4 weeks prior to&#xD;
                  dosing.&#xD;
&#xD;
               2. the absence of clinically significant history of neurological, endocrinal,&#xD;
                  cardiovascular, pulmonary, hematological, immunologic, psychiatric,&#xD;
                  gastrointestinal, renal, hepatic, and metabolic disease.&#xD;
&#xD;
          3. Females of childbearing potential must be willing to use acceptable contraceptive&#xD;
             method throughout the study and for 30 days after the last study drug administration:&#xD;
&#xD;
          4. Male subjects must be willing to use acceptable contraceptive method from the first&#xD;
             dosing until at least 90 days after the last study drug administration:&#xD;
&#xD;
          5. Male subjects (including men who have had vasectomies) with a pregnant partner must&#xD;
             agree to use a condom from the first dosing until at least 90 days after the last&#xD;
             study drug administration.&#xD;
&#xD;
          6. Male subjects must be willing not to donate sperm until 90 days following the last&#xD;
             study drug administration.&#xD;
&#xD;
          7. Capable of consent.&#xD;
&#xD;
          8. Consent to perform genotyping for CYP2D6.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any clinically significant abnormality at physical examination, clinically significant&#xD;
             abnormal laboratory test results&#xD;
&#xD;
          2. Positive urine drug screen or urine cotinine test at screening.&#xD;
&#xD;
          3. History of allergic reactions to GC4419, DM, or other related drugs.&#xD;
&#xD;
          4. Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days&#xD;
             prior to the first DM administration.&#xD;
&#xD;
          5. Poor CYP2D6 metabolizers as determined by genetic testing.&#xD;
&#xD;
          6. Positive pregnancy test at screening.&#xD;
&#xD;
          7. Any reason which, in the opinion of the Principal Investigator, would prevent the&#xD;
             subject from participating in the study.&#xD;
&#xD;
          8. Clinically significant ECG abnormalities or vital sign abnormalities&#xD;
&#xD;
          9. History of significant alcohol abuse within one year prior to screening or regular use&#xD;
             of alcohol within six months prior to the screening visit&#xD;
&#xD;
         10. History of significant drug abuse&#xD;
&#xD;
         11. Participation in a clinical research study involving the administration of an&#xD;
             investigational or marketed drug or device within 30 days prior to the first dosing,&#xD;
             administration of a biological product in the context of a clinical research study&#xD;
             within 90 days prior to the first dosing, or concomitant participation in an&#xD;
             investigational study involving no drug or device administration.&#xD;
&#xD;
         12. Use of medication other than hormonal contraceptives and topical products without&#xD;
             significant systemic absorption:&#xD;
&#xD;
         13. Donation of plasma within 7 days prior to dosing.&#xD;
&#xD;
         14. Breast-feeding subject.&#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>Inventiv Health Clinical - Research Pharmacy Unit</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>June 17, 2019</last_update_submitted>
  <last_update_submitted_qc>June 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dextromethorphan</mesh_term>
    <mesh_term>Avasopasem manganese</mesh_term>
  </intervention_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/NCT03792971
org study id: GTI-4419-005
nct id: NCT03792971
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This will be a single center, phase 1, open-label, fixed-sequence study under fasting
      conditions to evaluate the effect of 90 mg intravenous (IV) infusions of GC4419 on the
      single-dose pharmacokinetic (PK) of dextromethorphan (DM) capsules liquid filled.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-t
time frame: Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion
measure: Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-inf
time frame: Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion
measure: Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): Cmax
time frame: Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion
arm group label: Fixed Sequence
arm group type: Experimental
intervention type: Drug
intervention name: Dextromethorphan HBr
description: A single 60 mg dose of DM capsules liquid-filled on Day 1 and Day 3
arm group label: Fixed Sequence
intervention type: Drug
intervention name: GC4419
description: Daily 90 mg IV infusions over 60 minutes on Day 3 and Day 4
arm group label: Fixed Sequence
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dextromethorphan
mesh term: Avasopasem manganese
sharing ipd: No