<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/NCT02201849</url>
  </required_header>
  <id_info>
    <org_study_id>ALK8700-001</org_study_id>
    <nct_id>NCT02201849</nct_id>
  </id_info>
  <brief_title>A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults</brief_title>
  <official_title>A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biogen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biogen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a&#xD;
      monomethyl fumerate (MMF) molecule.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study record was previously posted/updated by Alkermes, Inc. As of 29 Oct 2019, the&#xD;
      sponsorship of the trial was transferred to Biogen along with responsibility for subsequent&#xD;
      updates to the record.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability will be measured by incidence of adverse events</measure>
    <time_frame>up to 27 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>up to 27 days</time_frame>
    <description>Concentrations will be measured predose and at 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to attain Cmax (Tmax)</measure>
    <time_frame>Up to 27 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast)</measure>
    <time_frame>Up to 27 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve from time 0 to infinity (AUCinf)</measure>
    <time_frame>Up to 27 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Study Drug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral capsules</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Study Drug</intervention_name>
    <arm_group_label>Study Drug</arm_group_label>
    <other_name>ALKS 8700 capsules</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Active Control</intervention_name>
    <arm_group_label>Active Control</arm_group_label>
    <other_name>TECFIDERA® capsules</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo capsules</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has a body-mass Index (BMI) &gt;/=18.0 and &lt;/=32.0 kg/m2&#xD;
&#xD;
          -  Agrees to use an acceptable method of contraception for the duration of the study and&#xD;
             for 30 days after any study drug administration&#xD;
&#xD;
          -  Additional criteria may apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is currently pregnant or breastfeeding&#xD;
&#xD;
          -  Has a lifetime history of menopausal hot flashes&#xD;
&#xD;
          -  Has a clinically significant medical condition&#xD;
&#xD;
          -  Has had a clinically significant illness in the 30 days prior to first study drug&#xD;
             administration&#xD;
&#xD;
          -  Has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to&#xD;
             study drug administration&#xD;
&#xD;
          -  Has had any vaccinations in the 4 weeks prior to inpatient admission&#xD;
&#xD;
          -  Has a lifetime history of diabetes&#xD;
&#xD;
          -  Additional criteria may apply&#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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Biogen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alkermes Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>November 22, 2019</last_update_submitted>
  <last_update_submitted_qc>November 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alkermes</keyword>
  <keyword>ALKS 8700</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dimethyl Fumarate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02201849
org study id: ALK8700-001
nct id: NCT02201849
lead sponsor: 
has dmc: No
This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a
      monomethyl fumerate (MMF) molecule.
This study record was previously posted/updated by Alkermes, Inc. As of 29 Oct 2019, the
      sponsorship of the trial was transferred to Biogen along with responsibility for subsequent
      updates to the record.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety and tolerability will be measured by incidence of adverse events
time frame: up to 27 days
measure: Maximum plasma concentration (Cmax)
time frame: up to 27 days
description: Concentrations will be measured predose and at 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose
measure: Time to attain Cmax (Tmax)
time frame: Up to 27 days
measure: Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast)
time frame: Up to 27 days
measure: Area under the concentration-time curve from time 0 to infinity (AUCinf)
time frame: Up to 27 days
arm group label: Study Drug
arm group type: Experimental
description: Oral capsules
arm group label: Active Control
arm group type: Active Comparator
description: Oral capsules
arm group label: Placebo
arm group type: Placebo Comparator
description: Oral capsules
intervention type: Drug
intervention name: Study Drug
arm group label: Study Drug
other name: ALKS 8700 capsules
intervention type: Drug
intervention name: Active Control
arm group label: Active Control
other name: TECFIDERA® capsules
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
other name: Placebo capsules
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Biogen
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Dimethyl Fumarate