xml: <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/NCT06014853</url>
    </required_header>
    <id_info>
      <org_study_id>DN-SOL-102</org_study_id>
      <nct_id>NCT06014853</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SOL-804 in Healthy Male Subjects</brief_title>
    <official_title>A Randomized, Open-label, Four-sequence, Four-period, Crossover, Single Dosing, Phase 1 Clinical Trial to Compare the Safety, Tolerability, and Pharmacokinetics of SOL-804 and Zytiga in Healthy Male Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bukwang Pharmaceutical</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Dyna Therapeutics</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Bukwang Pharmaceutical</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Study Design : A randomized, open-label, four-sequence, four-period, crossover, single&#xD;
        dosing, phase 1 study&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To evaluate the safety, tolerability and pharmacokinetic characteristics of SOL-804-F and&#xD;
        Zytiga tablets following a single oral dose and Zytiga 1,000 mg in healthy male volunteers.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>AUClast of abiraterone</measure>
      <time_frame>72 hours</time_frame>
      <description>Area under the plasma drug concentration-time curve from 0 to last</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cmax of abiraterone</measure>
      <time_frame>72 hours</time_frame>
      <description>The maximum or peak concentration between zero and dosing interval</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>AUCinf of abiraterone</measure>
      <time_frame>72 hours</time_frame>
      <description>Area under the plasma drug concentration-time curve from 0 to infinity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax of abiraterone</measure>
      <time_frame>72 hours</time_frame>
      <description>Time of Maximum Concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>t1/2 of abiraterone</measure>
      <time_frame>72 hours</time_frame>
      <description>Terminal Half-life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CL/F of abiraterone</measure>
      <time_frame>72 hours</time_frame>
      <description>An estimate of the total body clearance after oral administration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vd/F of abiraterone</measure>
      <time_frame>72 hours</time_frame>
      <description>Apparent volume of distribution after extravascular administration</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Rmax of serum testosterone</measure>
      <time_frame>72 hours</time_frame>
      <description>The maximum response</description>
    </other_outcome>
    <other_outcome>
      <measure>Imax of serum testosterone</measure>
      <time_frame>72 hours</time_frame>
      <description>Maximum inhibition</description>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Prostate Cancer</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Period 1: Zytiga® 1000mg / Period 2 : SOL-804-F 302.5mg / Period 3 : SOL-804-F 242.0mg / Period 4 : SOL-804-F 181.5mg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Period 1 : SOL-804-F 181.5mg / Period 2 : Zytiga® 1000mg / Period 3 : SOL-804-F 302.5mg / Period 4 : SOL-804-F 242.0mg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Period 1 : SOL-804-F 242.0mg / Period 2 : SOL-804-F 181.5mg / Period 3 Zytiga® 1000mg / Period 4 : SOL-804-F 302.5mg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 4</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Period 1 : SOL-804-F 302.5mg / Period 2 : SOL-804-F 242.0mg / Period 3 : SOL-804-F 181.5mg / Period 4 : Zytiga® 1000mg</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SOL-804-F</intervention_name>
      <description>All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with water on the administration day of each period.</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_label>Group 3</arm_group_label>
      <arm_group_label>Group 4</arm_group_label>
      <other_name>SOL-804-F 181.5mg/242.0mg/302.5mg</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Zytiga</intervention_name>
      <description>All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with water on the administration day of each period.</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_label>Group 3</arm_group_label>
      <arm_group_label>Group 4</arm_group_label>
      <other_name>Zytiga 500mg</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. healthy adult male volunteers between 19 to 50 years of age at screening visit.&#xD;
  &#xD;
            2. Body mass index (BMI) between 19.0 to 30.0 kg/m2&#xD;
  &#xD;
            3. The subjects voluntarily decide to participate in the study after receiving a full&#xD;
               explanation and understanding and provide written consent&#xD;
  &#xD;
            4. The subjects are suitable for this study as determined by the investigator (physical&#xD;
               examination, clinical laboratory tests, etc.)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Clinically significant abnormal physical examination, vital signs or ECG&#xD;
  &#xD;
            2. The subjects who have a medical history of hepatobiliary, renal, neurological, immune,&#xD;
               respiratory, endocrine, hematologic, oncologic, cardiovascular, urinary, psychiatric&#xD;
               or sexual dysfunction.&#xD;
  &#xD;
            3. The subjects who have a hereditary disorder including galactose intolerance, Lapp&#xD;
               lactase deficiency, glucose-galactose malabsorption, etc.&#xD;
  &#xD;
            4. The subjects who have a history of drug abuse or positive with urine drug screening&#xD;
               test&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>SeungHwan Lee</last_name>
      <role>Principal Investigator</role>
      <affiliation>Seoul National University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mira Son</last_name>
      <phone>82-2-828-8077</phone>
      <email>mi.ra.son@bukwang.co.kr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Seoul National University Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>03080</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>SeungHwan Lee</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Abiraterone</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Abiraterone Acetate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014853
  org study id: DN-SOL-102
  nct id: NCT06014853
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Study Design : A randomized, open-label, four-sequence, four-period, crossover, single
        dosing, phase 1 study
  To evaluate the safety, tolerability and pharmacokinetic characteristics of SOL-804-F and
        Zytiga tablets following a single oral dose and Zytiga 1,000 mg in healthy male volunteers.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: AUClast of abiraterone
  time frame: 72 hours
  description: Area under the plasma drug concentration-time curve from 0 to last
  measure: Cmax of abiraterone
  time frame: 72 hours
  description: The maximum or peak concentration between zero and dosing interval
  measure: AUCinf of abiraterone
  time frame: 72 hours
  description: Area under the plasma drug concentration-time curve from 0 to infinity
  measure: Tmax of abiraterone
  time frame: 72 hours
  description: Time of Maximum Concentration
  measure: t1/2 of abiraterone
  time frame: 72 hours
  description: Terminal Half-life
  measure: CL/F of abiraterone
  time frame: 72 hours
  description: An estimate of the total body clearance after oral administration
  measure: Vd/F of abiraterone
  time frame: 72 hours
  description: Apparent volume of distribution after extravascular administration
  measure: Rmax of serum testosterone
  time frame: 72 hours
  description: The maximum response
  measure: Imax of serum testosterone
  time frame: 72 hours
  description: Maximum inhibition
  arm group label: Group 1
  arm group type: Experimental
  description: Period 1: Zytiga® 1000mg / Period 2 : SOL-804-F 302.5mg / Period 3 : SOL-804-F 242.0mg / Period 4 : SOL-804-F 181.5mg
  arm group label: Group 2
  arm group type: Experimental
  description: Period 1 : SOL-804-F 181.5mg / Period 2 : Zytiga® 1000mg / Period 3 : SOL-804-F 302.5mg / Period 4 : SOL-804-F 242.0mg
  arm group label: Group 3
  arm group type: Experimental
  description: Period 1 : SOL-804-F 242.0mg / Period 2 : SOL-804-F 181.5mg / Period 3 Zytiga® 1000mg / Period 4 : SOL-804-F 302.5mg
  arm group label: Group 4
  arm group type: Experimental
  description: Period 1 : SOL-804-F 302.5mg / Period 2 : SOL-804-F 242.0mg / Period 3 : SOL-804-F 181.5mg / Period 4 : Zytiga® 1000mg
  intervention type: Drug
  intervention name: SOL-804-F
  description: All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with water on the administration day of each period.
  arm group label: Group 1
  arm group label: Group 2
  arm group label: Group 3
  arm group label: Group 4
  other name: SOL-804-F 181.5mg/242.0mg/302.5mg
  intervention type: Drug
  intervention name: Zytiga
  description: All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with water on the administration day of each period.
  arm group label: Group 1
  arm group label: Group 2
  arm group label: Group 3
  arm group label: Group 4
  other name: Zytiga 500mg
  criteria: 
  gender: Male
  minimum age: 19 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: SeungHwan Lee
  role: Principal Investigator
  affiliation: Seoul National University Hospital
  last name: Mira Son
  phone: 82-2-828-8077
  email: mi.ra.son@bukwang.co.kr
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  mesh term: Abiraterone Acetate
  sharing ipd: No