<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/NCT03244280</url>
  </required_header>
  <id_info>
    <org_study_id>MOB015B-VIII</org_study_id>
    <nct_id>NCT03244280</nct_id>
  </id_info>
  <brief_title>A Study of the Systemic Absorption of MOB015B</brief_title>
  <official_title>A Study of the Systemic Absorption of Once Daily MOB015B When Applied for 28 Days in Subjects With Moderate to Severe Onychomycosis of the Toenails.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Moberg Pharma AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Moberg Pharma AB</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Study of the Systemic Absorption of Once Daily MOB015B when Applied for 28 Days in Subjects&#xD;
      with Moderate to Severe Onychomycosis of the Toenails.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 16, 2017</start_date>
  <completion_date type="Actual">April 23, 2018</completion_date>
  <primary_completion_date type="Actual">April 23, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To measure the Cmax</measure>
    <time_frame>28 days</time_frame>
    <description>To measure the Cmax after 1 day and 28 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To measure the Tmax</measure>
    <time_frame>28 days</time_frame>
    <description>To measure Tmax after 1 day and 28 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>to measure AUC0-t</measure>
    <time_frame>28 days</time_frame>
    <description>To measure AUC0-t after 1 day and 28 days</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Onychomycosis</condition>
  <arm_group>
    <arm_group_label>MOB015B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MOB015B</intervention_name>
    <description>Topical formulation</description>
    <arm_group_label>MOB015B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who understand the study procedures and agree to participate by providing&#xD;
             written informed consent. Subject must be willing to authorize use and disclosure of&#xD;
             protected health information collected for the study.&#xD;
&#xD;
          2. Male or female subjects 12 to 70 years of age (inclusive), at the time of consent.&#xD;
&#xD;
          3. Subject has a body mass index (BMI) from ≥ 18.5 to ≤ 35.0 (kg/m2), at the screening&#xD;
             visit.&#xD;
&#xD;
          4. Females of childbearing potential must be using contraception during the study which&#xD;
             can include abstinence or hormonal contraceptives. All women of childbearing potential&#xD;
             must be willing to complete a urine pregnancy test on Days 1, 14, and 28.&#xD;
&#xD;
          5. Subjects must present with a clinical diagnosis of moderate to severe subungal&#xD;
             onychomycosis with at least 50% involvement of both great toenails. In addition, 4&#xD;
             other toenails must be affected.&#xD;
&#xD;
          6. Subjects must have a positive KOH microscopy for at least 1 great toenail at the&#xD;
             screening visit.&#xD;
&#xD;
          7. Subjects must be willing to complete clinical laboratory testing.&#xD;
&#xD;
          8. Subjects must be willing to undergo alcohol and drug (e.g., benzodiazepines, cocaine,&#xD;
             opioids, cannabinoids, and barbiturates) tests at the Day 1 visit.&#xD;
&#xD;
          9. Subjects must be willing to remain at the study site for approximately 11 hours and&#xD;
             undergo multiple blood draws on Day 1 and 28.&#xD;
&#xD;
         10. Subjects must be able to reach their toes to apply study drug or have a caregiver&#xD;
             willing to help apply the study drug on a daily basis as directed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female subjects who are pregnant, nursing/breastfeeding, or plan to become pregnant&#xD;
             within the study period.&#xD;
&#xD;
          2. Subjects with chronic or active liver disease, renal impairment, cutaneous or&#xD;
             systematic lupus erythematosus, or any other disease or medical condition that in the&#xD;
             opinion of the investigator would interfere with the study or place the subject at&#xD;
             undue risk.&#xD;
&#xD;
          3. Subject with hypersensitivity to terbinafine or the vehicle excipients.&#xD;
&#xD;
          4. Subjects who have been treated with systematic formulations of terbinafine in the 12&#xD;
             months prior to the Day 1 visit.&#xD;
&#xD;
          5. Subjects who have been treated with topical formulations of terbinafine in the 6&#xD;
             months prior to the day 1 visit.&#xD;
&#xD;
          6. Subjects who take or have taken systematic medication that may interfere with the&#xD;
             study or place the subject at undue risk in the 30 days before the day 1 visit (e.g.,&#xD;
             rifampin, cimetidine, phenobarbital, phenytoin, carbamazepine, terfenadine or&#xD;
             digoxin).&#xD;
&#xD;
          7. Subjects who take or have taken systemic medication in the 30 days before the Day 1&#xD;
             visit that interferes with the terbinafine plasma assay.&#xD;
&#xD;
          8. Subjects who have consumed grapefruit products during the 30 days prior to the Day 1&#xD;
             visit.&#xD;
&#xD;
          9. Subjects who are not willing to refrain from caffeinated beverage consumption on Day 1&#xD;
             and 28.&#xD;
&#xD;
         10. Subjects with a current history of consumption of more than three alcoholic drinks per&#xD;
             day or consumption of alcohol within 48 hours prior to Day 1 visit (one drink is equal&#xD;
             to one unit of alcohol, one glass of wine, half pint of beer or one ounce of spirits).&#xD;
&#xD;
         11. Subjects with an ongoing or recent history of treatment for substance abuse.&#xD;
&#xD;
         12. Subjects who have participated in a study of an investigational drug 60 days prior to&#xD;
             the Day 1 visit.&#xD;
&#xD;
         13. Subjects with a history of multiple syncopal episodes.&#xD;
&#xD;
         14. Subjects with positive tests for drugs or alcohol at Day 1 visit.&#xD;
&#xD;
         15. Subjects who are unable to comply with study requirements.&#xD;
&#xD;
         16. Subjects who are not willing to abstain from all toenail treatments such as toenail&#xD;
             polish, pedicures and/or foot soaks (including nail clipping or debridement), for 3&#xD;
             days prior to Day 1 visit and during the study.&#xD;
&#xD;
         17. Donation of blood (one unit or 350 mL) within 90 days prior to Day 1 visit.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dermatology clinic</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Onychomycosis</mesh_term>
  </condition_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/NCT03244280
org study id: MOB015B-VIII
nct id: NCT03244280
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
A Study of the Systemic Absorption of Once Daily MOB015B when Applied for 28 Days in Subjects
      with Moderate to Severe Onychomycosis of the Toenails.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: To measure the Cmax
time frame: 28 days
description: To measure the Cmax after 1 day and 28 days
measure: To measure the Tmax
time frame: 28 days
description: To measure Tmax after 1 day and 28 days
measure: to measure AUC0-t
time frame: 28 days
description: To measure AUC0-t after 1 day and 28 days
arm group label: MOB015B
arm group type: Other
intervention type: Drug
intervention name: MOB015B
description: Topical formulation
arm group label: MOB015B
criteria: 
gender: All
minimum age: 12 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Onychomycosis
sharing ipd: No