<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/NCT03751488</url>
  </required_header>
  <id_info>
    <org_study_id>LY03010/CT-USA-101</org_study_id>
    <nct_id>NCT03751488</nct_id>
  </id_info>
  <brief_title>A Study to Determine Pharmacokinetic Characteristics of LY03010 Versus INVEGA SUSTENNA® in Schizophrenia Patients</brief_title>
  <official_title>A Randomized, Single-Dose, Open-Label, Parallel-Group Study to Determine the Relative Pharmacokinetic Characteristics of LY03010 Versus INVEGA SUSTENNA® in Schizophrenia Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Luye Pharma Group Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Luye Pharma Group Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will look at the Characteristics of LY03010 Versus INVEGA SUSTENNA® in the blood&#xD;
      of Schizophrenia Patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">July 24, 2019</completion_date>
  <primary_completion_date type="Actual">July 24, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC</measure>
    <time_frame>Time Zero to Last quantifiable concentration (120 days)</time_frame>
    <description>Area under the concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CMax</measure>
    <time_frame>120 days</time_frame>
    <description>Maximum observed concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>120 days</time_frame>
    <description>Time to Reach Cmax</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety Assessments as measured by Adverse Events that occur during the study</measure>
    <time_frame>120 days</time_frame>
    <description>Safety Assessments as measured by Adverse Events that occur during the study</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Schizo Affective Disorder</condition>
  <condition>Schizophrenia</condition>
  <condition>Schizoaffective Disorder</condition>
  <arm_group>
    <arm_group_label>LY03010 351mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY03010 at 351 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY03010 156 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY03010 at 156 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY03010 117mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY03010 at 117mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>INVEGA SUSTENNA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>INVEGA SUSTENNA 156mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY03010</intervention_name>
    <description>Single Dose of LY03010 at 351 mg or 156 mg or 117mg</description>
    <arm_group_label>LY03010 117mg</arm_group_label>
    <arm_group_label>LY03010 156 mg</arm_group_label>
    <arm_group_label>LY03010 351mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Invega Sustenna 156 MG in 1 ML Prefilled Syringe</intervention_name>
    <description>Single Dose at 156mg</description>
    <arm_group_label>INVEGA SUSTENNA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Capable of giving informed consent and complying with study procedures;&#xD;
&#xD;
          2. Have an identified support person (e.g., family member, case worker, social worker)&#xD;
             considered reliable by the Investigator to help ensure compliance with study visits&#xD;
             and to alert staff of any issues of concern;&#xD;
&#xD;
          3. Have a stable place of residence for the 3 months prior to screening and throughout&#xD;
             the study;&#xD;
&#xD;
          4. Male or female ≥18 to ≤65 years of age who meets diagnostic criteria for schizophrenia&#xD;
             according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition&#xD;
             (DSM-V) for at least 1 year before screening;&#xD;
&#xD;
          5. Be on a stable dose of oral antipsychotic medication(s) other than risperidone,&#xD;
             paliperidone, clozapine, ziprasidone, or thioridazine for at least 4 weeks prior to&#xD;
             screening;&#xD;
&#xD;
          6. Be clinically stable based on clinical assessments and a Positive and Negative&#xD;
             Syndrome Scale (PANSS) total score ≤70 as well as a PANSS HATE (hostility, anxiety,&#xD;
             tension and excitement) subtotal score &lt;16 at screening;&#xD;
&#xD;
          7. Clinical Global Impression-Severity (CGI-S) score of 1 to 4, inclusive;&#xD;
&#xD;
          8. Body mass index (BMI) ≥17.0 and ≤37 kg/m2; body weight ≥50 kg;&#xD;
&#xD;
          9. Creatinine level within the normal range;&#xD;
&#xD;
         10. All female patients (childbearing potential and non-childbearing potential) must have&#xD;
             a negative pregnancy test result at both screening and baseline. Female patients must&#xD;
             meet 1 of the following 3 conditions: (i) postmenopausal for at least 12 months&#xD;
             without an alternative medical cause, (ii) surgically sterile (hysterectomy, bilateral&#xD;
             oophorectomy, bilateral salpingectomy, or bilateral tubal occlusion) based on patient&#xD;
             report, or (iii) if of childbearing potential (WOCBP), practicing or agree to practice&#xD;
             a highly effective contraception method of birth control. Highly effective methods of&#xD;
             birth control include an intrauterine device (IUD), intrauterine hormone-releasing&#xD;
             system (IUS), and contraceptives (oral, skin patches, or implanted or injectable&#xD;
             products) using combined or progestogen-only hormonal contraception associated with&#xD;
             inhibition of ovulation. A vasectomized male partner is an acceptable birth control&#xD;
             method if the vasectomized partner is the sole sexual partner of the female patient&#xD;
             and the vasectomized partner has received medical confirmation of surgical success.&#xD;
             Highly effective methods of birth control must be used for at least 14 days prior to&#xD;
             study drug dosing, throughout the study, and for another 80 days after the&#xD;
             end-of-treatment (EOT) visit (or at least 200 days after the dose, whichever is&#xD;
             longer) to minimize the risk of pregnancy;&#xD;
&#xD;
         11. Sexually active fertile male patients must be willing to use acceptable contraception&#xD;
             methods (such as double barrier methods of a combination of male condom with either&#xD;
             cap, diaphragm or sponge with spermicide) from study drug dosing, throughout the&#xD;
             study, and for another 80 days after the EOT visit (or at least 200 days after the&#xD;
             dose, whichever is longer) if their partners are women of childbearing potential.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Primary and active DSM-V Axis I diagnosis other than schizophrenia or schizoaffective&#xD;
             disorder;&#xD;
&#xD;
          2. Patients who meet DSM-V criteria for substance abuse (moderate or severe) with the&#xD;
             exception of caffeine or nicotine in the past 6 months prior to screening, or test&#xD;
             positive for a drug of abuse or alcohol at screening or baseline (except positive&#xD;
             findings that can be accounted for by documented prescriptions used as prescribed by a&#xD;
             treating physician as a part of the treatment for the patient's psychiatric illness);&#xD;
&#xD;
          3. History of treatment resistance, defined as failure to respond to 2 adequate treatment&#xD;
             regimens (minimum of 4 weeks at the patient's maximum tolerated dose) of different&#xD;
             antipsychotic medications;&#xD;
&#xD;
          4. Known or suspected hypersensitivity or intolerance of risperidone, paliperidone, or&#xD;
             any of their excipients (oral risperidone tolerability test will be completed during&#xD;
             the screening period, approximately 14 days prior to dosing, for patients without&#xD;
             documented evidence [medical record or written statement from a licensed medical&#xD;
             practitioner who has treated the patient] of tolerating risperidone or paliperidone,&#xD;
             and patients who show an allergic reaction to this test will be excluded from the&#xD;
             study);&#xD;
&#xD;
          5. Known non-responders to risperidone or paliperidone;&#xD;
&#xD;
          6. Patients who pose a significant risk of a suicide attempt based on history or the&#xD;
             Investigator's judgment; answer &quot;yes&quot; to Suicidal Ideation items 4 or 5 on the&#xD;
             Columbia Suicide Severity Rating Scale (C-SSRS) for current or past 30 days on the&#xD;
             &quot;Baseline/Screening version&quot; at screening; have had suicidal behavior in the last 12&#xD;
             months as measured by the C-SSRS at screening; or are at imminent risk of suicide or&#xD;
             violent behavior based on the Investigator's clinical assessment or the C-SSRS&#xD;
             assessment of lifetime suicidal ideation or behavior at screening;&#xD;
&#xD;
          7. Any one or more of the following 3 conditions: (i) clinically significant liver&#xD;
             dysfunction, (ii) hepatitis B surface antigen (HBsAg) positive, or (iii) a serum&#xD;
             alanine transaminase (ALT) or aspartate transaminase (AST) &gt; 2x upper limit of normal&#xD;
             (ULN) range (if the ALT or AST levels are between 2x and 3x ULN in the first screening&#xD;
             test and the elevation may be caused by non-specific reasons in the judgment of the&#xD;
             Investigator, a second test can be performed after one week. If the repeated ALT or&#xD;
             AST levels are still &gt;2x ULN, the patient must not be included in the study). However,&#xD;
             patients who are hepatitis C positive may be enrolled, if this condition is considered&#xD;
             stable without treatment and liver function is normal;&#xD;
&#xD;
          8. History of symptomatic orthostatic hypotension with a decrease of ≥20 mmHg in systolic&#xD;
             blood pressure (SBP) or decrease of ≥10 mmHg in diastolic blood pressure (DBP) when&#xD;
             changing from supine to standing position after having been in the supine position for&#xD;
             at least 5 minutes or SBP less than 105 mmHg in a supine position at screening;&#xD;
&#xD;
          9. Uncontrolled diabetes or hemoglobin A1c (HbAlc) level ≥7%, or newly diagnosed within&#xD;
             the past 12 months prior to screening;&#xD;
&#xD;
         10. History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia; history of&#xD;
             severe akathisia or extra-pyramidal reactions such as dystonia with previous use of&#xD;
             risperidone or other neuroleptic treatments; score ≥ 3 on the Global Clinical&#xD;
             Assessment of the BARS; or score ≥ 1 on the AIMS at screening. Patients who experience&#xD;
             mild extrapyramidal symptoms attributable to study medications will be allowed to&#xD;
             continue with appropriate anticholinergic treatment (benztropine, diphenhydramine,&#xD;
             and/or trihexyphenidyl);&#xD;
&#xD;
         11. Electroconvulsive therapy within 60 days before screening;&#xD;
&#xD;
         12. Use of a long-acting injectable for the treatment of schizophrenia within 4 weeks (8&#xD;
             weeks for Risperdal Consta®) before screening;&#xD;
&#xD;
         13. Use of injectable paliperidone palmitate within 10 months before screening;&#xD;
&#xD;
         14. Use of clozapine within 4 weeks before screening;&#xD;
&#xD;
         15. Use of nonselective or irreversible monoamine oxidase inhibitor (MAOI) antidepressants&#xD;
             within 30 days before screening;&#xD;
&#xD;
         16. Use of other antidepressants unless the patient has been on a stable dose for at least&#xD;
             30 days before screening;&#xD;
&#xD;
         17. Use of strong inducers of either CYP 3A4 or P-glycoprotein (P-gp) within 2 weeks or 5&#xD;
             half-lives, whichever is longer, before screening;&#xD;
&#xD;
         18. QTcF interval greater than 450 msec for males and 470 msec for females or a prior&#xD;
             history or presence of circumstances that could increase the risk of torsade de&#xD;
             pointes or sudden death in association with the use of drugs that prolong the QTc&#xD;
             interval, or other clinically significant ECG findings in the opinion of the&#xD;
             Investigator;&#xD;
&#xD;
         19. Clinically significant past medical history (within 2 years) of gastrointestinal,&#xD;
             cardiovascular, musculoskeletal, endocrine, hematologic, renal, hepatic,&#xD;
             bronchopulmonary, neurologic, immunologic disorders, or drug hypersensitivity which,&#xD;
             in the judgement of the Investigator, would interfere with the patient's ability to&#xD;
             participate in the study;&#xD;
&#xD;
         20. Malignancies with the exception of basal cell or squamous cell skin cancer or in situ&#xD;
             cervical cancer within 5 years prior to screening;&#xD;
&#xD;
         21. History or current diagnosis of epilepsy or convulsive disorder other than a single&#xD;
             childhood febrile seizure;&#xD;
&#xD;
         22. Participation in a previous clinical study of paliperidone or any other related&#xD;
             medications within the past 3 months prior to screening;&#xD;
&#xD;
         23. Receipt of another investigational product within 1 month, or 5 half-lives of the&#xD;
             other investigational product, whichever is longer, prior to screening;&#xD;
&#xD;
         24. Donation or blood collection of &gt; 1 unit (approximate 450 mL) of blood (or blood&#xD;
             products) or acute loss of blood during the 90 days prior to screening;&#xD;
&#xD;
         25. Any clinical observation or clinical laboratory abnormality including human&#xD;
             immunodeficiency virus (HIV) positive test result or abnormal ECG findings at&#xD;
             screening or baseline visits which, in the opinion of the Investigator, may endanger&#xD;
             the patient or interfere with the endpoints of the study. If the results of clinical&#xD;
             laboratory or ECG testing are outside normal reference ranges, the patient may be&#xD;
             enrolled but only if these findings are determined not to be clinically significant by&#xD;
             the Investigator. This determination must be recorded in the patient's source&#xD;
             documents.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Sun, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Luye Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Collaborative Neuroscience Network LLC</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hassman Research Institute</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>August 12, 2019</last_update_submitted>
  <last_update_submitted_qc>August 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paliperidone Palmitate</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/NCT03751488
org study id: LY03010/CT-USA-101
nct id: NCT03751488
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will look at the Characteristics of LY03010 Versus INVEGA SUSTENNA® in the blood
      of Schizophrenia Patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC
time frame: Time Zero to Last quantifiable concentration (120 days)
description: Area under the concentration
measure: CMax
time frame: 120 days
description: Maximum observed concentration
measure: Tmax
time frame: 120 days
description: Time to Reach Cmax
measure: Safety Assessments as measured by Adverse Events that occur during the study
time frame: 120 days
description: Safety Assessments as measured by Adverse Events that occur during the study
arm group label: LY03010 351mg
arm group type: Experimental
description: LY03010 at 351 mg
arm group label: LY03010 156 mg
arm group type: Experimental
description: LY03010 at 156 mg
arm group label: LY03010 117mg
arm group type: Experimental
description: LY03010 at 117mg
arm group label: INVEGA SUSTENNA
arm group type: Active Comparator
description: INVEGA SUSTENNA 156mg
intervention type: Drug
intervention name: LY03010
description: Single Dose of LY03010 at 351 mg or 156 mg or 117mg
arm group label: LY03010 117mg
arm group label: LY03010 156 mg
arm group label: LY03010 351mg
intervention type: Drug
intervention name: Invega Sustenna 156 MG in 1 ML Prefilled Syringe
description: Single Dose at 156mg
arm group label: INVEGA SUSTENNA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Amy Sun, MD PhD
role: Study Director
affiliation: Luye Pharma
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Psychotic Disorders
mesh term: Mood Disorders
mesh term: Paliperidone Palmitate
sharing ipd: No