<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/NCT03810625</url>
  </required_header>
  <id_info>
    <org_study_id>IBIO-302</org_study_id>
    <nct_id>NCT03810625</nct_id>
  </id_info>
  <brief_title>Food Effect Study of D-0502 Tablet in Healthy Volunteers</brief_title>
  <official_title>A Phase I, Randomized, Open Label, Two-Sequence, Two-Period Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of D-0502 Tablet in Postmenopausal Female Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InventisBio Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InventisBio Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</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 is an open label, randomized, balanced, single dose, two-treatment (fed vs. fasting),&#xD;
      two-period, two-sequence crossover study of postmenopausal female healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2018</start_date>
  <completion_date type="Actual">April 17, 2019</completion_date>
  <primary_completion_date type="Actual">November 21, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic: area under the plasma concentration versus time curve (AUC)</measure>
    <time_frame>Day 1 through 4, Day 7 through 11</time_frame>
    <description>AUC: area under the plasma concentration versus time curve for D-0502; Unit: nM*hr</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic: maximum plasma drug concentration (Cmax)</measure>
    <time_frame>Day 1 through 4, Day 7 through 11</time_frame>
    <description>Cmax: maximum plasma drug concentration of D-0502; Unit: nM</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic: Time to reach the Cmax (Tmax)</measure>
    <time_frame>Day 1 through 4, Day 7 through 11</time_frame>
    <description>Tmax: Time to reach the Cmax of D-0502; Unit: hr</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic: Apparent terminal half-life (t1/2)</measure>
    <time_frame>Day 1 through 4, Day 7 through 11</time_frame>
    <description>t1/2: apparent terminal half-life of D-0502; Unit: hr</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>2 weeks</time_frame>
    <description>Number of treatment-related adverse events as assessed by CTCAE v4.0</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Sequence AB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>D-0502 Dose Patients will get D-0502 single agent once in the fasted state and once in the fed state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence BA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>D-0502 Dose Patients will get D-0502 single agent once in the fed state and once in the fasted state.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>D-0502</intervention_name>
    <description>D-0502 oral tablets</description>
    <arm_group_label>Sequence AB</arm_group_label>
    <arm_group_label>Sequence BA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects must be medically documented as healthy and acceptable at physical&#xD;
             examination.&#xD;
&#xD;
          2. Subjects must have a BMI between 18.0 and 32.0 kg/m2 and a body weight of 45 kg or&#xD;
             higher.&#xD;
&#xD;
          3. Subjects must have all laboratory parameters within the normal range or considered not&#xD;
             clinically significant by the principal investigator.&#xD;
&#xD;
          4. Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically&#xD;
             significant by the principal investigator.&#xD;
&#xD;
          5. Subjects must be female with postmenopausal status defined as meeting at least one of&#xD;
             the following criteria:&#xD;
&#xD;
               1. Have undergone a bilateral oophorectomy any time in life;&#xD;
&#xD;
               2. Age ≥60 years, or&#xD;
&#xD;
               3. Age &lt;60 years but have cessation of regular menses ≥12 months with follicle&#xD;
                  stimulating hormone (FSH) value &gt;40 milli-international units per milliliter&#xD;
                  (mIU/mL) and an estradiol value &lt;40 picograms per milliliter (pg/mL) (140&#xD;
                  picomoles per liter [pmol/L]).&#xD;
&#xD;
          6. Subjects are able to understand the study procedures and risks involved and must&#xD;
             provide signed informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with any history or clinical manifestations of significant metabolic,&#xD;
             hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic,&#xD;
             renal, urological or psychiatric disorders, as determined by the investigator.&#xD;
&#xD;
          2. Subjects who have any history or suspicion of kidney stones.&#xD;
&#xD;
          3. Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B, and/or&#xD;
             Hepatitis C.&#xD;
&#xD;
          4. Subjects who have used prescription drugs, over-the-counter drugs, or natural health&#xD;
             products (including herbal remedies, homeopathic and traditional medicines,&#xD;
             probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty&#xD;
             acids, and protein supplements used in sports) within 14 days before Day 1 of study&#xD;
             medication dosing.&#xD;
&#xD;
          5. Subjects had undergone major surgery within 3 months prior to Day 1.&#xD;
&#xD;
          6. Subjects who is participating in a clinical research study involving the&#xD;
             administration of an investigational or marketed drug or device, or who received any&#xD;
             investigational test article within 5 half-lives or 30 days prior to Day 1 study&#xD;
             medication dosing.&#xD;
&#xD;
          7. Subjects with positive urine drug screen test at screening.&#xD;
&#xD;
          8. Subjects with any condition that, in the judgment of the investigator, would place&#xD;
             him/her at undue risk, or potentially compromise the results or interpretation of the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Covance Daytona Beach Clinical Research Unit</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 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 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03810625
org study id: IBIO-302
nct id: NCT03810625
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is an open label, randomized, balanced, single dose, two-treatment (fed vs. fasting),
      two-period, two-sequence crossover study of postmenopausal female healthy subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
time frame: Day 1 through 4, Day 7 through 11
description: AUC: area under the plasma concentration versus time curve for D-0502; Unit: nM*hr
measure: Pharmacokinetic: maximum plasma drug concentration (Cmax)
time frame: Day 1 through 4, Day 7 through 11
description: Cmax: maximum plasma drug concentration of D-0502; Unit: nM
measure: Pharmacokinetic: Time to reach the Cmax (Tmax)
time frame: Day 1 through 4, Day 7 through 11
description: Tmax: Time to reach the Cmax of D-0502; Unit: hr
measure: Pharmacokinetic: Apparent terminal half-life (t1/2)
time frame: Day 1 through 4, Day 7 through 11
description: t1/2: apparent terminal half-life of D-0502; Unit: hr
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 2 weeks
description: Number of treatment-related adverse events as assessed by CTCAE v4.0
arm group label: Sequence AB
arm group type: Experimental
description: D-0502 Dose Patients will get D-0502 single agent once in the fasted state and once in the fed state.
arm group label: Sequence BA
arm group type: Experimental
description: D-0502 Dose Patients will get D-0502 single agent once in the fed state and once in the fasted state.
intervention type: Drug
intervention name: D-0502
description: D-0502 oral tablets
arm group label: Sequence AB
arm group label: Sequence BA
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor