<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/NCT03776968</url>
  </required_header>
  <id_info>
    <org_study_id>HC-1119-PK</org_study_id>
    <nct_id>NCT03776968</nct_id>
  </id_info>
  <brief_title>A Study Evaluating HC-1119 Single-Dose Pharmacokinetics and Effect of Food on Its Pharmacokinetics</brief_title>
  <official_title>A Study Evaluating HC-1119 Single-Dose Pharmacokinetics and Effect of Food on Its Pharmacokinetics in Healthy Chinese Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hinova Pharmaceuticals Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hinova Pharmaceuticals Inc.</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 is a phase I study evaluating HC-1119 single-dose pharmacokinetics and effect of food on&#xD;
      its pharmacokinetics in healthy Chinese adults. The study primary objective is to evaluate&#xD;
      the HC-1119 pharmacokinetic characteristics and the effect of food on its pharmacokinetics in&#xD;
      healthy Chinese males, subsequent to a single oral administration of HC-1119 with different&#xD;
      doses in healthy Chinese males.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2017</start_date>
  <completion_date type="Actual">July 3, 2018</completion_date>
  <primary_completion_date type="Actual">January 15, 2018</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 to infinity (∞) (AUC0-∞)</measure>
    <time_frame>From the first dose of the study drug to day 50</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration(AUC0-t)</measure>
    <time_frame>From the first dose of the study drug to day 50</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak concentration (Cmax)</measure>
    <time_frame>From the first dose of the study drug to day 50</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak time (Tmax)</measure>
    <time_frame>From the first dose of the study drug to day 50</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Elimination half life (t1/2)</measure>
    <time_frame>From the first dose of the study drug to day 50</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent clearance (CL/F) (prototype)</measure>
    <time_frame>From the first dose of the study drug to day 50</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution (Vd/F) (prototype)</measure>
    <time_frame>From the first dose of the study drug to day 50</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>From the first dose of the study drug to day 50</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>From the first dose of the study drug to day 50</time_frame>
    <description>Safety measures</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Metastatic Castration Resistant Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>HC1119</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fasting state:40 mg, 80 mg, 160 mg; After meal: 160mg;</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HC1119</intervention_name>
    <description>oral</description>
    <arm_group_label>HC1119</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntarily signed the informed consent form.&#xD;
&#xD;
          2. Healthy Chinese male aged between 18-45 years old (inclusive).&#xD;
&#xD;
          3. Weight ≥ 50.0 kg, and BMI between 19.0-26.0 kg/m2 (inclusive) at screening. BMI =&#xD;
             weight (kg) / height2 (m2).&#xD;
&#xD;
          4. Defined as &quot;healthy&quot; based on past medical history, physical examination, vital signs,&#xD;
             laboratory tests, 12-Lead ECG, and chest x-ray performed at screening. All examination&#xD;
             results must be within the normal range corresponding to the subject's age and gender,&#xD;
             or determined by the investigator as &quot;no clinical significance (NCS)&quot; when the result&#xD;
             is out of range.&#xD;
&#xD;
          5. All male subjects and their female spouses/sexual partners with child-bearing&#xD;
             potential must adopt continuous and effective contraceptive methods, that is, two&#xD;
             forms of contraception should be performed spontaneously (including at least one&#xD;
             barrier method), from the initiation of screening and the whole study period to at&#xD;
             least three months after administration.&#xD;
&#xD;
          6. Able to maintain a consistency of good communication with the investigators, and&#xD;
             understand and comply with all the requirements of this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A history of cardiovascular, lung, hepatic, renal, respiratory, nervous system,&#xD;
             musculoskeletal, endocrine, or GI disease, or a history of other serious systemic&#xD;
             diseases.&#xD;
&#xD;
          2. A clinically significant history of drug allergies or a history of specific allergic&#xD;
             disease (asthma, urticaria, eczema dermatitis), especially being allergic to any&#xD;
             ingredients of the study drug or formulation.&#xD;
&#xD;
          3. Suffered (within 1 week prior to the study) or currently suffering from febrile&#xD;
             illness, symptomatic viral infection, bacterial infection (including upper respiratory&#xD;
             tract infection), or fungal infection (except skin infection).&#xD;
&#xD;
          4. Administered any prescription drugs, Chinese herbal medicine, OTC drugs, or food&#xD;
             supplements (including vitamins) within 4 weeks prior to the study.&#xD;
&#xD;
          5. Administered any inducers or inhibitors of hepatic drug metabolism within 1 month&#xD;
             prior to the study (such as: inducers - barbiturates, carbamazepine, phenytoin,&#xD;
             glucocorticoids, and omeprazole; inhibitors - antidepressants, cimetidine, diltiazem,&#xD;
             macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, and&#xD;
             antihistamines).&#xD;
&#xD;
          6. History of seizures within 12 months prior to the study, including any history of&#xD;
             febrile seizures, loss of consciousness, or transient ischemic attack, and any&#xD;
             condition that increases the risk of seizures (such as history of stroke, cerebral&#xD;
             arteriovenous malformation, traumatic brain injury with coma requiring&#xD;
             hospitalization, and lacunar infarct).&#xD;
&#xD;
          7. Recent history (in the past 3 years) and/or current medical history of autonomic&#xD;
             dysfunction (such as recurrent syncope and palpitations).&#xD;
&#xD;
          8. History of medication abuse or a positive urine drug screen within 12 months prior to&#xD;
             the study.&#xD;
&#xD;
          9. Smokers or those who smoked more than 10 cigarettes per day (or equivalent amounts of&#xD;
             tobacco) within 3 months prior to the study, or those who are unable to stop smoking&#xD;
             during the entire course of the study.&#xD;
&#xD;
         10. History of alcohol abuse or those with regular consumption of alcoholic beverages&#xD;
             (daily consumption exceeding 14 units of alcohol, 1 unit = 360 ml of beer, 45 ml of&#xD;
             40% liquor, or 150 ml of wine) within 6 months prior to the study, or having a&#xD;
             positive breath alcohol test result.&#xD;
&#xD;
         11. Donated or lost blood ≥ 400 ml of blood within 3 months prior to the study.&#xD;
&#xD;
         12. Received treatment with any investigational drug or participated in any clinical trial&#xD;
             within 3 months prior to the study.&#xD;
&#xD;
         13. Requiring a special diet and unable to follow a standardized diet.&#xD;
&#xD;
         14. Overconsumption of tea, coffee, and/or caffeinated beverages daily (more than 8 cups,&#xD;
             1 cup = 250 ml).&#xD;
&#xD;
         15. Consumed grapefruit or product containing grapefruit (such as jam) within 1 week prior&#xD;
             to receiving the investigational drug.&#xD;
&#xD;
         16. Positive HIV, HBsAg, HCV, or syphilis test result.&#xD;
&#xD;
         17. Cannot complete this study for any other reasons, or determined by the investigator to&#xD;
             be unsuitable for this study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shanghai Changhai Hospital Ethics Committee</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>October 30, 2020</last_update_submitted>
  <last_update_submitted_qc>October 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03776968
org study id: HC-1119-PK
nct id: NCT03776968
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a phase I study evaluating HC-1119 single-dose pharmacokinetics and effect of food on
      its pharmacokinetics in healthy Chinese adults. The study primary objective is to evaluate
      the HC-1119 pharmacokinetic characteristics and the effect of food on its pharmacokinetics in
      healthy Chinese males, subsequent to a single oral administration of HC-1119 with different
      doses in healthy Chinese males.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the plasma concentration-time curve from time 0 to infinity (∞) (AUC0-∞)
time frame: From the first dose of the study drug to day 50
measure: Area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration(AUC0-t)
time frame: From the first dose of the study drug to day 50
measure: Peak concentration (Cmax)
time frame: From the first dose of the study drug to day 50
measure: Peak time (Tmax)
time frame: From the first dose of the study drug to day 50
measure: Elimination half life (t1/2)
time frame: From the first dose of the study drug to day 50
measure: Apparent clearance (CL/F) (prototype)
time frame: From the first dose of the study drug to day 50
measure: Apparent volume of distribution (Vd/F) (prototype)
time frame: From the first dose of the study drug to day 50
measure: Mean residence time (MRT)
time frame: From the first dose of the study drug to day 50
measure: Number of patients with adverse events
time frame: From the first dose of the study drug to day 50
description: Safety measures
arm group label: HC1119
arm group type: Experimental
description: Fasting state:40 mg, 80 mg, 160 mg; After meal: 160mg;
intervention type: Drug
intervention name: HC1119
description: oral
arm group label: HC1119
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Prostatic Neoplasms