<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/NCT03002935</url>
  </required_header>
  <id_info>
    <org_study_id>BP 0312-02</org_study_id>
    <nct_id>NCT03002935</nct_id>
  </id_info>
  <brief_title>A Safety Study of Orally Administered BPM31510 in Healthy Subjects</brief_title>
  <official_title>A Phase I Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Orally Administered BPM31510 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Berg, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Berg, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, Phase I study of the bioavailability and safety of BPM31510&#xD;
      administered orally in healthy subjects dosed 3 times daily for 14 days. The last study dose&#xD;
      is administered on Day 15 (one morning dose only). The study will consist of 25 subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study subjects will be admitted to the clinic on Day -1. All subjects will self-administer&#xD;
      the Day 1 doses of study drug under supervision of the clinic staff. Doses of 3200 mg will be&#xD;
      administered three times per day before meals.&#xD;
&#xD;
      Dosing will continue for an additional 14 days on an outpatient basis with Day 5 morning dose&#xD;
      and the last study dose on Day 15 to be administered at the clinic (one morning dose, is&#xD;
      given on Day 15).&#xD;
&#xD;
      On Days 1, 2, 5 and 15, pharmacokinetic (PK) and pharmacodynamics (PD) sampling will be&#xD;
      performed 30 minutes prior to the first dose, and 0.5, 1, 2, and 4 hours after the first dose&#xD;
      at all visits with an additional PK draw on Day 1 at 0.5, 1, 2, and 4 after the second dose.&#xD;
      Urine for PK/PD will be collected pre-dose on Day 1, Day 2, Day 5 and Day 15. At all visits&#xD;
      (on Days 1, 2, 5 and at the final dose on Day 15), samples will be collected for chemistry,&#xD;
      Complete Blood Count (CBC), International normalized ratio (INR), prothrombin time (PT),&#xD;
      partial thromboplastin time (PTT), cholesterol, low density lipoprotein (LDL), and high&#xD;
      density lipoprotein (HDL), and vitamin K level. Blood samples for PK/PD will be collected 30&#xD;
      minutes prior to the morning dose on Day 5 and Day 15 and also at 0.5, 1, 2, and 4 hours&#xD;
      after dosing. Lab samples (chemistry, etc.), will also be drawn at the time of the first&#xD;
      PK/PD draw on Day 5 and Day 15.&#xD;
&#xD;
      A phone interview will be conducted no fewer than 25 days and no more than 35 days after the&#xD;
      last dose on Day 15 to collect information on concomitant medications and adverse events&#xD;
      Graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>Days 1, 2, 5, 15; baseline pre-dosing concentrations</time_frame>
    <description>Pharmacokinetic (PK) samples collected to establish oral bioavailability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration curve (AUC0-4)</measure>
    <time_frame>Days 1, 2, 5, 15; baseline pre-dosing concentrations</time_frame>
    <description>Pharmacokinetic (PK) samples collected to establish oral bioavailability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of study subjects with adverse events</measure>
    <time_frame>Baseline to 25-35 days after the end of dosing</time_frame>
    <description>A follow-up phone interview with each study subject will occur 25 to 35 days after the end of dosing to measure the number of adverse events that have occurred.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein measurement</measure>
    <time_frame>Days 1, 2, 5, 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol measurement</measure>
    <time_frame>Days 1, 2, 5, 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low density lipoprotein (LDL) measurement</measure>
    <time_frame>Days 1, 2, 5, 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High density lipoprotein (HDL) measurement</measure>
    <time_frame>Days 1, 2, 5, 15</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BPM31510 Oral Nanosuspension 4%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study subjects will self-administer 80 mL (4 vials of 20 mL) of oral BPM31510 (Ubidecarenone, USP; 40 mg/mL) nano-suspension 3 times daily every 4 to 6 hours for a total daily dose 9600 mg/day of BPM31510 for 14 consecutive days. The last study dose (morning dose only) is administered at the clinic on Day 15.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BPM31510 Oral Nanosuspension 4%</intervention_name>
    <description>Oral nanosuspension formulation of BPM31510 (ubidecarenone, USP)</description>
    <arm_group_label>BPM31510 Oral Nanosuspension 4%</arm_group_label>
    <other_name>Coenzyme Q10, CoQ10, ubidecarenone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women, age &gt;18 years&#xD;
&#xD;
          -  Body mass index (BMI)≥19 and ≤30&#xD;
&#xD;
          -  Good health conditions or without significant illness, by judgment of a legally&#xD;
             qualified professional, according to the following evaluations: medical history,&#xD;
             physical examination, vital signs, electrocardiogram (ECG), and screening or baseline&#xD;
             hematology and clinical chemistry measures.&#xD;
&#xD;
          -  Subjects of child bearing potential must agree to use one of the accepted methods of&#xD;
             contraception (listed below) during the trial (including the screening period prior to&#xD;
             receiving trial medication), at least until return of menstruation after stopping the&#xD;
             trial medication.&#xD;
&#xD;
               -  condom (male or female) with spermicide&#xD;
&#xD;
               -  diaphragm or cervical cap with spermicide&#xD;
&#xD;
               -  Intrauterine device (IUD)&#xD;
&#xD;
               -  hormonal contraception and condom (male or female)&#xD;
&#xD;
          -  Female subjects must have a negative pregnancy test result at screening and Day-1&#xD;
&#xD;
          -  PT/PTT/INR within normal limits&#xD;
&#xD;
          -  Vitamin K levels within normal limits&#xD;
&#xD;
          -  Capable of understanding and complying with the protocol and signing informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating female subjects&#xD;
&#xD;
          -  Known hypersensitivity to the study drug (Coenzyme Q10) or to compounds chemically&#xD;
             related&#xD;
&#xD;
          -  History or presence of hepatic or gastrointestinal illnesses, or other condition that&#xD;
             interferes with the drug's absorption, distribution, excretion or metabolism&#xD;
&#xD;
          -  History of hepatic, renal, pulmonary, gastrointestinal, epileptic, hematologic or&#xD;
             psychiatric illness&#xD;
&#xD;
          -  Hypotension or hypertension of any etiologic that needs pharmacologic treatment&#xD;
&#xD;
          -  History of or existing coagulopathy&#xD;
&#xD;
          -  History of myocardial infarction, angina, and/or heart insufficiency&#xD;
&#xD;
          -  Non-recommended electrocardiographic findings, according to investigator criteria&#xD;
&#xD;
          -  Results of the laboratory exams out of normal range unless that they are considered as&#xD;
             clinically irrelevant by the investigator&#xD;
&#xD;
          -  Subject is a smoker&#xD;
&#xD;
          -  Subject ingests more than 5 cups of coffee or tea a day&#xD;
&#xD;
          -  History of alcohol or drug abuse&#xD;
&#xD;
          -  History of serious adverse reactions or hypersensitivity to any drug&#xD;
&#xD;
          -  On-going regular use of oral prescription drugs, with the exception of oral&#xD;
             contraceptives&#xD;
&#xD;
          -  Hospitalization for any reason within 8 weeks prior to study dosing&#xD;
&#xD;
          -  Participation in any experimental study or ingested any experimental drug within 30&#xD;
             days preceding study&#xD;
&#xD;
          -  Donation or loss of 450 mL or more of blood within the 3 months prior to&#xD;
             Screening/Baseline&#xD;
&#xD;
          -  Subject consumed alcohol 48 hours prior to the baseline measurements of the study&#xD;
&#xD;
          -  Subject reports history of human immunodeficiency virus&#xD;
&#xD;
          -  Currently using coenzyme Q10 over-the-counter products&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magdy Shenouda, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinilabs, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinilabs Inc.</name>
      <address>
        <city>Eatontown</city>
        <state>New Jersey</state>
        <zip>07724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>April 4, 2017</last_update_submitted>
  <last_update_submitted_qc>April 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coenzyme Q10</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/NCT03002935
org study id: BP 0312-02
nct id: NCT03002935
lead sponsor: 
has dmc: No
This is an open-label, Phase I study of the bioavailability and safety of BPM31510
      administered orally in healthy subjects dosed 3 times daily for 14 days. The last study dose
      is administered on Day 15 (one morning dose only). The study will consist of 25 subjects.
Study subjects will be admitted to the clinic on Day -1. All subjects will self-administer
      the Day 1 doses of study drug under supervision of the clinic staff. Doses of 3200 mg will be
      administered three times per day before meals.

      Dosing will continue for an additional 14 days on an outpatient basis with Day 5 morning dose
      and the last study dose on Day 15 to be administered at the clinic (one morning dose, is
      given on Day 15).

      On Days 1, 2, 5 and 15, pharmacokinetic (PK) and pharmacodynamics (PD) sampling will be
      performed 30 minutes prior to the first dose, and 0.5, 1, 2, and 4 hours after the first dose
      at all visits with an additional PK draw on Day 1 at 0.5, 1, 2, and 4 after the second dose.
      Urine for PK/PD will be collected pre-dose on Day 1, Day 2, Day 5 and Day 15. At all visits
      (on Days 1, 2, 5 and at the final dose on Day 15), samples will be collected for chemistry,
      Complete Blood Count (CBC), International normalized ratio (INR), prothrombin time (PT),
      partial thromboplastin time (PTT), cholesterol, low density lipoprotein (LDL), and high
      density lipoprotein (HDL), and vitamin K level. Blood samples for PK/PD will be collected 30
      minutes prior to the morning dose on Day 5 and Day 15 and also at 0.5, 1, 2, and 4 hours
      after dosing. Lab samples (chemistry, etc.), will also be drawn at the time of the first
      PK/PD draw on Day 5 and Day 15.

      A phone interview will be conducted no fewer than 25 days and no more than 35 days after the
      last dose on Day 15 to collect information on concomitant medications and adverse events
      Graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum plasma concentration (Cmax)
time frame: Days 1, 2, 5, 15; baseline pre-dosing concentrations
description: Pharmacokinetic (PK) samples collected to establish oral bioavailability.
measure: Area under the plasma concentration curve (AUC0-4)
time frame: Days 1, 2, 5, 15; baseline pre-dosing concentrations
description: Pharmacokinetic (PK) samples collected to establish oral bioavailability.
measure: Number of study subjects with adverse events
time frame: Baseline to 25-35 days after the end of dosing
description: A follow-up phone interview with each study subject will occur 25 to 35 days after the end of dosing to measure the number of adverse events that have occurred.
measure: C-reactive protein measurement
time frame: Days 1, 2, 5, 15
measure: Cholesterol measurement
time frame: Days 1, 2, 5, 15
measure: Low density lipoprotein (LDL) measurement
time frame: Days 1, 2, 5, 15
measure: High density lipoprotein (HDL) measurement
time frame: Days 1, 2, 5, 15
arm group label: BPM31510 Oral Nanosuspension 4%
arm group type: Experimental
description: Study subjects will self-administer 80 mL (4 vials of 20 mL) of oral BPM31510 (Ubidecarenone, USP; 40 mg/mL) nano-suspension 3 times daily every 4 to 6 hours for a total daily dose 9600 mg/day of BPM31510 for 14 consecutive days. The last study dose (morning dose only) is administered at the clinic on Day 15.
intervention type: Drug
intervention name: BPM31510 Oral Nanosuspension 4%
description: Oral nanosuspension formulation of BPM31510 (ubidecarenone, USP)
arm group label: BPM31510 Oral Nanosuspension 4%
other name: Coenzyme Q10, CoQ10, ubidecarenone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Magdy Shenouda, MD
role: Principal Investigator
affiliation: Clinilabs, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coenzyme Q10
sharing ipd: No