<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/NCT03768388</url>
  </required_header>
  <id_info>
    <org_study_id>COR-2017-02</org_study_id>
    <nct_id>NCT03768388</nct_id>
  </id_info>
  <brief_title>Levoketoconazole Food Effect Study in Healthy Subjects</brief_title>
  <official_title>A Phase I Randomized, Open-Label, Two-Period, Two-Sequence Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Levoketoconazole in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cortendo AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cortendo AB</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 is a phase I, randomized, open-label, single-dose, two-period, two-sequence crossover&#xD;
      study in healthy male and female subjects to evaluate the effect of food on the PK of&#xD;
      levoketoconazole.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In each period of the randomized, two period crossover study, levoketoconazole will be&#xD;
      administered orally as a single dose of 600 mg levoketoconazole to subjects in the fasted&#xD;
      state or fed (at 30 minutes after beginning consumption of a standardized high-fat meal).&#xD;
      Subjects assigned to one treatment in Period 1 will be assigned to the opposite treatment in&#xD;
      Period 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">December 24, 2018</completion_date>
  <primary_completion_date type="Actual">December 24, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of levoketoconazole</measure>
    <time_frame>24 hours</time_frame>
    <description>Maximum observed plasma concentration (Cmax) of levoketoconazole for fed vs. fasted condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to maximum concentration (Tmax) of levoketoconazole</measure>
    <time_frame>24 hours</time_frame>
    <description>Time to maximum concentration (Tmax) of levoketoconazole for fed vs. fasted condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Elimination Phase Rate Constant (λz) of levoketoconazole</measure>
    <time_frame>24 hours</time_frame>
    <description>Apparent Terminal Elimination Phase Rate Constant (λz) of levoketoconazole for fed vs. fasted condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal phase half-life (t 1/2) of levoketoconazole</measure>
    <time_frame>24 hours</time_frame>
    <description>Terminal phase half-life (t 1/2) of levoketoconazole for fed vs. fasted condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC) of levoketoconazole</measure>
    <time_frame>24 hours</time_frame>
    <description>Area under the plasma concentration-time curve (AUC) from time 0 to time of last measurable plasma concentration (AUClast) and from time 0 extrapolated to infinity (AUCinf) of levoketoconazole for fed vs. fasted condition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events</measure>
    <time_frame>14 days</time_frame>
    <description>AEs leading to discontinuation, AEs of Special Interest (AESIs), AEs related to study drug and AE severity will be summarized by study treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Fasting State</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A single 600 mg dose of levoketoconazole administered in a fasting state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fed State</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A single 600 mg dose of levoketoconazole administered in a fed state.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>levoketoconazole</intervention_name>
    <description>food effect</description>
    <arm_group_label>Fasting State</arm_group_label>
    <arm_group_label>Fed State</arm_group_label>
    <other_name>COR-003</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is 18-55 years of age, inclusive, at time of consent.&#xD;
&#xD;
          2. Subject has a body mass index (BMI) between 18 and 32 kg/m2, inclusive.&#xD;
&#xD;
          3. Subject is in good general physical health as determined by absence of clinically&#xD;
             significant medical history, physical examination findings, vital signs, clinical&#xD;
             laboratory evaluations, and ECG measurements.&#xD;
&#xD;
          4. Subject has not consumed and agrees to abstain from taking any prescription drugs,&#xD;
             dietary supplements including vitamins and herbal preparations, or non-prescription&#xD;
             drugs (except as authorized by the Investigator AND Medical Monitor) for 14 days prior&#xD;
             to CRU admission, during washout period, and through Follow-Up.&#xD;
&#xD;
          5. Subject has not consumed alcohol-containing beverages for 3 days prior to CRU&#xD;
             admission and agrees not to consume alcohol through Follow-Up.&#xD;
&#xD;
          6. Subject is a nonsmoker (for at least 3 months) with negative urinary cotinine test at&#xD;
             Screening and agrees to abstain from tobacco- and nicotine-containing products for the&#xD;
             duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of any out-of-normal-range laboratory value at Screening that has not been&#xD;
             reviewed, approved, and documented as Not Clinically Significant by the Investigator.&#xD;
&#xD;
          2. Concurrent medical illness that would interfere with the conduct of the study in the&#xD;
             opinion of the Investigator.&#xD;
&#xD;
          3. History or presence of clinically significant cardiovascular, pulmonary, hematologic,&#xD;
             endocrine, immunologic, dermatologic, neurologic, psychiatric, renal, hepatic, chronic&#xD;
             respiratory, or gastrointestinal disease as judged by the Investigator.&#xD;
&#xD;
          4. Positive urine drug screen for drugs-of-abuse, including cocaine,&#xD;
             tetrahydrocannabinol, opioids, benzodiazepines, amphetamines, and barbiturates, and/or&#xD;
             positive urine screen for alcohol at Screening and CRU admission.&#xD;
&#xD;
          5. Treatment with an investigational drug within the longer of 30 days or five half-lives&#xD;
             of the investigational drug preceding the first dose of study drug.&#xD;
&#xD;
          6. Subject is positive for Human Immunodeficiency Virus (HIV), hepatitis B, and/or&#xD;
             hepatitis C on Screening assessments.&#xD;
&#xD;
          7. Subject has an acute illness within 7 days of CRU admission.&#xD;
&#xD;
          8. Subject has donated plasma within 7 days of drug administration.&#xD;
&#xD;
          9. Subject has donated 1 or more pints of blood (or equivalent blood loss) within 30 days&#xD;
             prior to drug administration.&#xD;
&#xD;
         10. History of caffeine consumption exceeding 8 cups of coffee/day (1 cup = 8 fluid&#xD;
             ounces) within 14 days prior to first dose, or consumption of any caffeine- or&#xD;
             chocolate-containing products for 3 days prior to CRU admission each week.&#xD;
             Caffeine-containing foods and/or beverages (e.g., tea and cola) should be considered&#xD;
             equivalent to coffee.&#xD;
&#xD;
         11. Female subjects who are pregnant or lactating.&#xD;
&#xD;
         12. Males with hemoglobin less than 12.0 g/dL; Females with hemoglobin less than 11.0&#xD;
             g/dL.&#xD;
&#xD;
         13. Subjects who have had difficulties with swallowing whole tablets.&#xD;
&#xD;
         14. Subjects with body habitus preventing repeated venipuncture as required by protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Schoenfeld, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cortendo AB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Pharmacology of Miami, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03768388
org study id: COR-2017-02
nct id: NCT03768388
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a phase I, randomized, open-label, single-dose, two-period, two-sequence crossover
      study in healthy male and female subjects to evaluate the effect of food on the PK of
      levoketoconazole.
In each period of the randomized, two period crossover study, levoketoconazole will be
      administered orally as a single dose of 600 mg levoketoconazole to subjects in the fasted
      state or fed (at 30 minutes after beginning consumption of a standardized high-fat meal).
      Subjects assigned to one treatment in Period 1 will be assigned to the opposite treatment in
      Period 2.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Maximum observed plasma concentration (Cmax) of levoketoconazole
time frame: 24 hours
description: Maximum observed plasma concentration (Cmax) of levoketoconazole for fed vs. fasted condition
measure: Time to maximum concentration (Tmax) of levoketoconazole
time frame: 24 hours
description: Time to maximum concentration (Tmax) of levoketoconazole for fed vs. fasted condition
measure: Apparent Terminal Elimination Phase Rate Constant (λz) of levoketoconazole
time frame: 24 hours
description: Apparent Terminal Elimination Phase Rate Constant (λz) of levoketoconazole for fed vs. fasted condition
measure: Terminal phase half-life (t 1/2) of levoketoconazole
time frame: 24 hours
description: Terminal phase half-life (t 1/2) of levoketoconazole for fed vs. fasted condition
measure: Area under the plasma concentration-time curve (AUC) of levoketoconazole
time frame: 24 hours
description: Area under the plasma concentration-time curve (AUC) from time 0 to time of last measurable plasma concentration (AUClast) and from time 0 extrapolated to infinity (AUCinf) of levoketoconazole for fed vs. fasted condition
measure: Incidence of Adverse Events
time frame: 14 days
description: AEs leading to discontinuation, AEs of Special Interest (AESIs), AEs related to study drug and AE severity will be summarized by study treatment
arm group label: Fasting State
arm group type: Other
description: A single 600 mg dose of levoketoconazole administered in a fasting state.
arm group label: Fed State
arm group type: Other
description: A single 600 mg dose of levoketoconazole administered in a fed state.
intervention type: Drug
intervention name: levoketoconazole
description: food effect
arm group label: Fasting State
arm group label: Fed State
other name: COR-003
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steven Schoenfeld, MD
role: Study Director
affiliation: Cortendo AB
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No