<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/NCT03822065</url>
  </required_header>
  <id_info>
    <org_study_id>LY03005/CT-USA-105</org_study_id>
    <nct_id>NCT03822065</nct_id>
  </id_info>
  <brief_title>A Relative Bioavailability Food Effect Study of LY03005</brief_title>
  <official_title>A Randomized, Open-Label, 2-Period, Crossover Trial to Assess the Relative Bioavailability of 80 mg LY03005 After Single Dose Administration to Healthy Subjects Under Fed Versus Fasted Conditions</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>
      The objective if this study is to assess the relative bio-availability of single oral doses&#xD;
      of 80 mg LY03005 tablets administered to healthy subjects under fed versus fasted conditions&#xD;
      in a 2-period, crossover trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty-two (32) eligible healthy subjects between ages of 18-50 years old will be enrolled&#xD;
      and randomized to either Sequence 1 (fed to fasted state) versus Sequence 2 (fasted to fed&#xD;
      state) at a 1:1 ratio.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Actual">February 16, 2019</completion_date>
  <primary_completion_date type="Actual">February 16, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic Parameters</measure>
    <time_frame>PK samples drawn at predose (within 30 minutes prior to dosing) and at 1, 2, 3, 4 (±5 minutes), 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours (±15 minutes) after the dose.</time_frame>
    <description>Area under the concentration-time curve (AUC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Parameters</measure>
    <time_frame>PK samples drawn at predose (within 30 minutes prior to dosing) and at 1, 2, 3, 4 (±5 minutes), 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours (±15 minutes) after the dose.</time_frame>
    <description>Maximum concentration (Cmax) for the Pharmacokinetics (PK) of O-desmethyl-venlafaxine (ODV) from LY03005</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Sequence 1: LY03005 Fed Crossover to Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sequence 1 will receive a single oral dose of LY03005 (80 mg) under fed conditions in Treatment Period 1 and a single oral dose of LY03005 (80 mg) under fasted conditions in Treatment Period 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2: LY03005 Fasted Crossover to Fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sequence 2 will receive a single oral dose of LY03005 (80 mg) under fasted conditions in Treatment Period 1 and a single oral dose of LY03005 (80 mg) under fed conditions in Treatment Period 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY03005</intervention_name>
    <description>80 mg oral tablet single dose</description>
    <arm_group_label>Sequence 1: LY03005 Fed Crossover to Fasted</arm_group_label>
    <arm_group_label>Sequence 2: LY03005 Fasted Crossover to Fed</arm_group_label>
    <other_name>Desvenlafaxine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Capable of giving informed consent and complying with trial procedures;&#xD;
&#xD;
          2. Male and female subjects between the ages of 18 and 50 years, inclusive;&#xD;
&#xD;
          3. Considered healthy by the Investigator based on a detailed medical history, full&#xD;
             physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;&#xD;
&#xD;
          4. Nonsmoker, defined as not having smoked or used any form of tobacco for at least 6&#xD;
             months before Screening based on subject report;&#xD;
&#xD;
          5. Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight &gt;/= 50 kg;&#xD;
&#xD;
          6. Willing and able to adhere to trial procedures and to be confined at the clinical&#xD;
             research unit (CRU).&#xD;
&#xD;
          7. All female subjects (childbearing potential and non-childbearing potential) must have&#xD;
             a negative serum pregnancy test result at Screening. In addition, female subjects must&#xD;
             meet 1 of the following 3 conditions: (a) 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 subject&#xD;
             report, or (iii) if of childbearing potential and heterosexually active, practicing or&#xD;
             agree to practice a highly effective method of contraception. Highly effective methods&#xD;
             of 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 subject&#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, through the end of study (EOS) visit or early termination, and for&#xD;
             a minimum of 1 month after the last dose of study drug to minimize the risk of&#xD;
             pregnancy. Sexually active, fertile, male subjects must be willing to use acceptable&#xD;
             contraception methods (such as double-barrier methods of a combination of male condom&#xD;
             with either cap, diaphragm, or sponge with spermicide) from the first dose of study&#xD;
             drug through the EOS visit or early termination, and for a minimum of 1 month after&#xD;
             the last dose of study drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically significant past medical history of gastrointestinal, cardiovascular,&#xD;
             musculoskeletal, endocrine, hematologic, psychiatric (including life-long history of&#xD;
             depression and/or anxiety), renal, hepatic, bronchopulmonary, neurologic, immunologic,&#xD;
             ophthalmological, or lipid metabolism disorders; or drug hypersensitivity; or any&#xD;
             condition that in the judgement of the Investigator will affect the trial results or&#xD;
             the subject's safety;&#xD;
&#xD;
          2. History of suicide attempt in the past 12 months and/or seen by the Investigator as&#xD;
             having a significant history of risk of suicide or homicide;&#xD;
&#xD;
          3. History or presence of malignancy other than adequately treated and cured basal cell&#xD;
             skin cancer, squamous cell skin cancer, or in-situ cervical cancer, within 5 years&#xD;
             prior to screening;&#xD;
&#xD;
          4. Clinically relevant illness within 1 month prior to Screening or at Screening that may&#xD;
             interfere with the conduct of this trial;&#xD;
&#xD;
          5. Medically uncontrolled high blood pressure with mean systolic blood pressure &gt;140 mmHg&#xD;
             or mean diastolic blood pressure &gt;90 mmHg at Screening after 3 measurements (after at&#xD;
             least 5 minutes of rest in a seated position);&#xD;
&#xD;
          6. History of Long QT Syndrome (LQTS) or a marked baseline prolongation of QT/QTc&#xD;
             interval (e.g., repeated demonstration of a QTc interval &gt;450 ms);&#xD;
&#xD;
          7. Positive blood screen for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C&#xD;
             antibody;&#xD;
&#xD;
          8. History of seizure (history of febrile seizure allowed);&#xD;
&#xD;
          9. Hospital admission or major surgery within 30 days prior to Screening;&#xD;
&#xD;
         10. Participation in any other investigational drug trial within 30 days prior to&#xD;
             Screening;&#xD;
&#xD;
         11. History of prescription drug abuse or illicit drug use within 6 months prior to&#xD;
             Screening;&#xD;
&#xD;
         12. History of alcohol abuse according to medical history within 6 months prior to&#xD;
             Screening;&#xD;
&#xD;
         13. Positive screen for alcohol and/or drugs of abuse;&#xD;
&#xD;
         14. Tobacco use within 6 months prior to Screening based on subject report or positive&#xD;
             nicotine screen;&#xD;
&#xD;
         15. History of intolerance or hypersensitivity to ODV or medicines containing ODV or its&#xD;
             precursor venlafaxine;&#xD;
&#xD;
         16. Participation in a previous clinical trial of either LY03005 or ODV or medicines&#xD;
             containing ODV or its precursor, venlafaxine, within 30 days prior to Screening;&#xD;
&#xD;
         17. Unwillingness or inability to comply with food and beverage restrictions during trial&#xD;
             participation;&#xD;
&#xD;
         18. Donation of blood of more than 1 unit (approximate 450 mL) or blood products or acute&#xD;
             loss of blood during the 90 days prior to Screening;&#xD;
&#xD;
         19. Use of prescription or over-the-counter (OTC) medications and herbals (including St&#xD;
             John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing (Note: Use&#xD;
             of acetaminophen at &lt;3g/day is permitted until 24 hours prior to dosing).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin Booth, MD, DVM</last_name>
    <role>Study Director</role>
    <affiliation>Luye Pharma.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pharmaron CPC, Inc.</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://druginfo.nlm.nih.gov/drugportal/</url>
    <description>Drug information</description>
  </link>
  <link>
    <url>https://druginfo.nlm.nih.gov/drugportal/name/Desvenlafaxine</url>
    <description>Desvenlafaxine</description>
  </link>
  <link>
    <url>https://druginfo.nlm.nih.gov/drugportal/name/desvenlafaxine%20succinate</url>
    <description>Desvenlafaxine Succinate</description>
  </link>
  <link>
    <url>https://clinicaltrials.gov/ct2/info/fdalinks</url>
    <description>U.S. FDA Resources</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>August 5, 2019</last_update_submitted>
  <last_update_submitted_qc>August 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depressive Disorder, Major</keyword>
  <keyword>Depressive Disorder</keyword>
  <keyword>Mood Disorders</keyword>
  <keyword>Mental Disorders</keyword>
  <keyword>Desvenlafaxine Succinate</keyword>
  <keyword>Serotonin and Noradrenaline Reuptake Inhibitors</keyword>
  <keyword>Neurotransmitter Uptake Inhibitors</keyword>
  <keyword>Membrane Transport Modulators</keyword>
  <keyword>Molecular Mechanisms of Pharmacological Action</keyword>
  <keyword>Neurotransmitter Agents</keyword>
  <keyword>Physiological Effects of Drugs</keyword>
  <keyword>Antidepressive Agents</keyword>
  <keyword>Psychotropic Drugs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Desvenlafaxine Succinate</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/NCT03822065
org study id: LY03005/CT-USA-105
nct id: NCT03822065
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The objective if this study is to assess the relative bio-availability of single oral doses
      of 80 mg LY03005 tablets administered to healthy subjects under fed versus fasted conditions
      in a 2-period, crossover trial.
Thirty-two (32) eligible healthy subjects between ages of 18-50 years old will be enrolled
      and randomized to either Sequence 1 (fed to fasted state) versus Sequence 2 (fasted to fed
      state) at a 1:1 ratio.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetic Parameters
time frame: PK samples drawn at predose (within 30 minutes prior to dosing) and at 1, 2, 3, 4 (±5 minutes), 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours (±15 minutes) after the dose.
description: Area under the concentration-time curve (AUC)
measure: Pharmacokinetic Parameters
time frame: PK samples drawn at predose (within 30 minutes prior to dosing) and at 1, 2, 3, 4 (±5 minutes), 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours (±15 minutes) after the dose.
description: Maximum concentration (Cmax) for the Pharmacokinetics (PK) of O-desmethyl-venlafaxine (ODV) from LY03005
arm group label: Sequence 1: LY03005 Fed Crossover to Fasted
arm group type: Experimental
description: Sequence 1 will receive a single oral dose of LY03005 (80 mg) under fed conditions in Treatment Period 1 and a single oral dose of LY03005 (80 mg) under fasted conditions in Treatment Period 2.
arm group label: Sequence 2: LY03005 Fasted Crossover to Fed
arm group type: Experimental
description: Sequence 2 will receive a single oral dose of LY03005 (80 mg) under fasted conditions in Treatment Period 1 and a single oral dose of LY03005 (80 mg) under fed conditions in Treatment Period 2.
intervention type: Drug
intervention name: LY03005
description: 80 mg oral tablet single dose
arm group label: Sequence 1: LY03005 Fed Crossover to Fasted
arm group label: Sequence 2: LY03005 Fasted Crossover to Fed
other name: Desvenlafaxine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kevin Booth, MD, DVM
role: Study Director
affiliation: Luye Pharma.
facility: 
country: United States
url: https://druginfo.nlm.nih.gov/drugportal/
description: Drug information
url: https://druginfo.nlm.nih.gov/drugportal/name/Desvenlafaxine
description: Desvenlafaxine
url: https://druginfo.nlm.nih.gov/drugportal/name/desvenlafaxine%20succinate
description: Desvenlafaxine Succinate
url: https://clinicaltrials.gov/ct2/info/fdalinks
description: U.S. FDA Resources
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
mesh term: Desvenlafaxine Succinate
sharing ipd: No