<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/NCT04499209</url>
  </required_header>
  <id_info>
    <org_study_id>XG005-01</org_study_id>
    <nct_id>NCT04499209</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics Study of XG005 Capsule</brief_title>
  <official_title>A Phase 1, Single-Center, Randomized, Placebo-Controlled, Ascending Single-Dose Study of the Pharmacokinetics, Safety, and Tolerability of Oral XG005 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xgene Pharmaceutical Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xgene Pharmaceutical Group</source>
  <oversight_info>
    <has_dmc>No</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 was a Phase 1, single-center, randomized, placebo-controlled, 2-period, ascending&#xD;
      single-dose study assessing the PK, safety, and tolerability of single ascending doses of&#xD;
      XG005 (Period 1) and the naproxen and pregabalin combination (Period 2), in 5 dose groups&#xD;
      each with 10 subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Period 1 was double-blind and randomized 8 subjects (1:1 allocation ratio by gender) to XG005&#xD;
      and 2 subjects (1:1 allocation ratio by gender) to placebo. Subjects were enrolled&#xD;
      sequentially into a total of 5 ascending dose levels pending safety review, and PK review&#xD;
      where possible, of Period 1 of the prior dose level. Sentinel dose participants (1 for XG005&#xD;
      and 1 for placebo) were included as the first dose administered at each dose level in Period&#xD;
      1.&#xD;
&#xD;
      In Period 2, all subjects in the last three XG005 dose groups received approximate molar&#xD;
      equivalents of naproxen and pregabalin corresponding to XG005 doses after a 7-day washout&#xD;
      period. Period 2 was open-label with 10 subjects per group.&#xD;
&#xD;
      PK blood samples in each treatment period were collected at 0 (pre-dosing), 0.5, 1, 1.5, 2,&#xD;
      3, 4, 6, 8, 12, 24, 48, and 72 hrs after drug administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Actual">March 19, 2018</completion_date>
  <primary_completion_date type="Actual">January 18, 2018</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>Period 1: ascending single-dose of XG005 vs Placebo; Period 2: combination of Naproxen and Pregabalin</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Period 1: Participants and investigators were blinded Period 2: Open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum concentration (Cmax)</measure>
    <time_frame>Day1 to Day 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to maximum concentration (Tmax)</measure>
    <time_frame>Day1 to Day 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)</measure>
    <time_frame>Day1 to Day 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration-time curve from time 0 to infinity (AUC0-inf)</measure>
    <time_frame>Day1 to Day 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal Elimination Rate Constant (kel)</measure>
    <time_frame>Day1 to Day 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal half-life (t1/2)</measure>
    <time_frame>Day1 to Day 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal clearance (CL/F)</measure>
    <time_frame>Day1 to Day 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of distribution (Vd/F)</measure>
    <time_frame>Day1 to Day 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence and severity of adverse events (AEs)</measure>
    <time_frame>Day -1 to Day 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>Day -1 to Day 8</time_frame>
    <description>vital signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>Day -1 to Day 8</time_frame>
    <description>vital signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>respiratory rate</measure>
    <time_frame>Day -1 to Day 8</time_frame>
    <description>vital signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>temperature</measure>
    <time_frame>Day -1 to Day 8</time_frame>
    <description>vital signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical examination</measure>
    <time_frame>Day -1 to Day 8</time_frame>
    <description>Cardiovascular, Ears, Nose and Throat, Eyes, Gastrointestinal, Head, Lymph Nodes, Musculoskeletal, Neurological, Respiratory, Skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>electrocardiogram (ECG) parameters;</measure>
    <time_frame>Day -1 to Day 8</time_frame>
    <description>ECG-PR, RR, QRS, QT, and QTc intervals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical laboratory parameters -chemistry</measure>
    <time_frame>Day -1 to Day 8</time_frame>
    <description>BUN, Creatinine, Total bilirubin, Total protein, Alkaline phosphatase, Uric Acid, Estimated creatinine clearance, Creatine Phosphokinase (CPK), AST (SGOT), ALT (SGPT), Glucose, Sodium, Potassium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical laboratory parameters- hematology</measure>
    <time_frame>Day -1 to Day 8</time_frame>
    <description>Hemoglobin, Hematocrit, Red Blood Cell Count, White Blood Cell Count with differential, Platelet Count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical laboratory parameters urinalysis</measure>
    <time_frame>Day -1 to Day 8</time_frame>
    <description>pH • Specific gravity • Protein&#xD;
Glucose • Ketones • Bilirubin&#xD;
Blood • Nitrite • Urobilinogen&#xD;
Leukocytes</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Period 1- XG005</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>XG005 capsule in 4 dose level</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Period 2- Naproxen and Pregabalin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Combination of Naproxen and Pregabalin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Period 1- Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>XG005 matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XG005</intervention_name>
    <description>XG005 Capsule</description>
    <arm_group_label>Period 1- XG005</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Combination of Naproxen and Pregabalin</intervention_name>
    <description>Naproxen and Pregabalin are commercially available products with trade names of Aleve and Lyrica</description>
    <arm_group_label>Period 2- Naproxen and Pregabalin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Placebo Capsule</description>
    <arm_group_label>Period 1- Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI range of 18-30 kg/m2&#xD;
&#xD;
          -  Medically healthy subjects&#xD;
&#xD;
          -  Creatinine clearance ≥ 80 mL/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of significant diseases&#xD;
&#xD;
          -  History or presence of alcoholism or drug abuse&#xD;
&#xD;
          -  Consumption of alcohol 48 hours prior each dose&#xD;
&#xD;
          -  Hypersensitivity or idiosyncratic reaction to the study drug&#xD;
&#xD;
          -  Abnormal diet (for whatever reason) during the 30 days prior to the first dosing;&#xD;
&#xD;
          -  Donation (standard donation amount or more) of blood or blood products&#xD;
&#xD;
          -  Plasma donation within 7 days prior to the study;&#xD;
&#xD;
          -  Participation in another clinical trial within 30 days prior to the first dose;&#xD;
&#xD;
          -  Female subjects who are pregnant or lactating;&#xD;
&#xD;
          -  Hemoglobin &lt; 120 g/L&#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>Linear Clinical Research Ltd</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 14, 2020</last_update_submitted>
  <last_update_submitted_qc>August 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</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>Naproxen</mesh_term>
    <mesh_term>Pregabalin</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/NCT04499209
org study id: XG005-01
nct id: NCT04499209
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This was a Phase 1, single-center, randomized, placebo-controlled, 2-period, ascending
      single-dose study assessing the PK, safety, and tolerability of single ascending doses of
      XG005 (Period 1) and the naproxen and pregabalin combination (Period 2), in 5 dose groups
      each with 10 subjects.
Period 1 was double-blind and randomized 8 subjects (1:1 allocation ratio by gender) to XG005
      and 2 subjects (1:1 allocation ratio by gender) to placebo. Subjects were enrolled
      sequentially into a total of 5 ascending dose levels pending safety review, and PK review
      where possible, of Period 1 of the prior dose level. Sentinel dose participants (1 for XG005
      and 1 for placebo) were included as the first dose administered at each dose level in Period
      1.

      In Period 2, all subjects in the last three XG005 dose groups received approximate molar
      equivalents of naproxen and pregabalin corresponding to XG005 doses after a 7-day washout
      period. Period 2 was open-label with 10 subjects per group.

      PK blood samples in each treatment period were collected at 0 (pre-dosing), 0.5, 1, 1.5, 2,
      3, 4, 6, 8, 12, 24, 48, and 72 hrs after drug administration.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Period 1: ascending single-dose of XG005 vs Placebo; Period 2: combination of Naproxen and Pregabalin
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: Period 1: Participants and investigators were blinded Period 2: Open label
measure: Maximum concentration (Cmax)
time frame: Day1 to Day 4
measure: Time to maximum concentration (Tmax)
time frame: Day1 to Day 4
measure: Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
time frame: Day1 to Day 4
measure: Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
time frame: Day1 to Day 4
measure: Terminal Elimination Rate Constant (kel)
time frame: Day1 to Day 4
measure: Terminal half-life (t1/2)
time frame: Day1 to Day 4
measure: Terminal clearance (CL/F)
time frame: Day1 to Day 4
measure: Volume of distribution (Vd/F)
time frame: Day1 to Day 4
measure: incidence and severity of adverse events (AEs)
time frame: Day -1 to Day 8
measure: blood pressure
time frame: Day -1 to Day 8
description: vital signs
measure: heart rate
time frame: Day -1 to Day 8
description: vital signs
measure: respiratory rate
time frame: Day -1 to Day 8
description: vital signs
measure: temperature
time frame: Day -1 to Day 8
description: vital signs
measure: physical examination
time frame: Day -1 to Day 8
description: Cardiovascular, Ears, Nose and Throat, Eyes, Gastrointestinal, Head, Lymph Nodes, Musculoskeletal, Neurological, Respiratory, Skin
measure: electrocardiogram (ECG) parameters;
time frame: Day -1 to Day 8
description: ECG-PR, RR, QRS, QT, and QTc intervals
measure: clinical laboratory parameters -chemistry
time frame: Day -1 to Day 8
description: BUN, Creatinine, Total bilirubin, Total protein, Alkaline phosphatase, Uric Acid, Estimated creatinine clearance, Creatine Phosphokinase (CPK), AST (SGOT), ALT (SGPT), Glucose, Sodium, Potassium
measure: clinical laboratory parameters- hematology
time frame: Day -1 to Day 8
description: Hemoglobin, Hematocrit, Red Blood Cell Count, White Blood Cell Count with differential, Platelet Count
measure: clinical laboratory parameters urinalysis
time frame: Day -1 to Day 8
description: pH • Specific gravity • Protein
Glucose • Ketones • Bilirubin
Blood • Nitrite • Urobilinogen
Leukocytes
arm group label: Period 1- XG005
arm group type: Experimental
description: XG005 capsule in 4 dose level
arm group label: Period 2- Naproxen and Pregabalin
arm group type: Active Comparator
description: Combination of Naproxen and Pregabalin
arm group label: Period 1- Placebo
arm group type: Placebo Comparator
description: XG005 matching placebo
intervention type: Drug
intervention name: XG005
description: XG005 Capsule
arm group label: Period 1- XG005
intervention type: Drug
intervention name: Combination of Naproxen and Pregabalin
description: Naproxen and Pregabalin are commercially available products with trade names of Aleve and Lyrica
arm group label: Period 2- Naproxen and Pregabalin
intervention type: Drug
intervention name: Placebos
description: Placebo Capsule
arm group label: Period 1- Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Naproxen
mesh term: Pregabalin
sharing ipd: No