<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/NCT03033498</url>
  </required_header>
  <id_info>
    <org_study_id>M15-738</org_study_id>
    <nct_id>NCT03033498</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease</brief_title>
  <official_title>A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 24 Hour and 72 Hour Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess the safety, tolerability, and pharmacokinetics of&#xD;
      single, ascending doses of ABBV-951 administered as a subcutaneous bolus infusion followed by&#xD;
      a continuous subcutaneous infusion in subjects with Parkinson's disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 17, 2017</start_date>
  <completion_date type="Actual">June 8, 2019</completion_date>
  <primary_completion_date type="Actual">June 8, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of Levodopa</measure>
    <time_frame>Hour 0-24</time_frame>
    <description>Maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to maximum observed plasma concentration (Tmax) of Levodopa</measure>
    <time_frame>Hour 0-24</time_frame>
    <description>Time to maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve (AUC) of Levodopa</measure>
    <time_frame>Hour 0-24</time_frame>
    <description>Area under the plasma concentration-time curve following a single infusion of ABBV-951.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>24 hours</time_frame>
    <description>Number of participants reporting adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal phase elimination rate constant (β)</measure>
    <time_frame>Up to 72 hours</time_frame>
    <description>Apparent terminal phase elimination rate constant (β or Beta)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal phase elimination half-life (T1/2)</measure>
    <time_frame>Up to 72 hours</time_frame>
    <description>Terminal phase elimination half-life (t1/2) will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Corrected QT (QTc) Interval</measure>
    <time_frame>Up to 76 hours</time_frame>
    <description>QT interval adjusted for heart rate.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Parkinson's Disease (PD)</condition>
  <arm_group>
    <arm_group_label>ABBV-951 Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive dose 1 of ABBV-951.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABBV-951 Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive dose 2 of ABBV-951.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABBV-951 Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive dose 3 of ABBV-951.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABBV-951 Dose 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive dose 4 of ABBV-951.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABBV-951 Dose 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive dose 5 of ABBV-951.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABBV-951 Dose 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive dose 6 of ABBV-951.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABBV-951 Dose 7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive dose 7 of ABBV-951.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABBV-951 Dose 8</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive dose 8 of ABBV-951.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABBV-951</intervention_name>
    <description>ABBV-951 administered by subcutaneous infusion.</description>
    <arm_group_label>ABBV-951 Dose 1</arm_group_label>
    <arm_group_label>ABBV-951 Dose 2</arm_group_label>
    <arm_group_label>ABBV-951 Dose 3</arm_group_label>
    <arm_group_label>ABBV-951 Dose 4</arm_group_label>
    <arm_group_label>ABBV-951 Dose 5</arm_group_label>
    <arm_group_label>ABBV-951 Dose 6</arm_group_label>
    <arm_group_label>ABBV-951 Dose 7</arm_group_label>
    <arm_group_label>ABBV-951 Dose 8</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has a diagnosis of definite idiopathic PD, which is LD responsive, according&#xD;
             to the United Kingdom Parkinson's Disease Society Brain Bank Criteria.&#xD;
&#xD;
          -  Subject must be taking an optimized and stable regimen of oral medications for PD,&#xD;
             which has remained stable and unchanged for at least 30 days before dosing in this&#xD;
             study. This regimen must include oral carbidopa/levodopa (CD/LD) tablets (e.g.,&#xD;
             Sinemet).&#xD;
&#xD;
          -  Females must have negative results for pregnancy tests at screening and prior to&#xD;
             confinement.&#xD;
&#xD;
          -  If male, subject must be surgically sterile or practicing an adequate method of birth&#xD;
             control from initial study drug administration until 30 days after last dose of study&#xD;
             drug.&#xD;
&#xD;
          -  Body Mass Index (BMI) is 18.0 to 38.0, inclusive.&#xD;
&#xD;
          -  A condition of general good health, based upon the results of a medical history,&#xD;
             physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram&#xD;
             (ECG).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receipt of any drug by injection within 30 days or within a period defined by 5&#xD;
             half-lives, whichever is longer, prior to study drug administration.&#xD;
&#xD;
          -  History of significant skin conditions or disorders (e.g., psoriasis, atopic&#xD;
             dermatitis, etc.) or evidence of recent sunburn, acne, scar tissue, tattoo, open&#xD;
             wound, branding, or colorations that in the Investigator's opinion would interfere&#xD;
             with the infusion of the study drug or could interfere with study assessments.&#xD;
&#xD;
          -  Use of any medication from the prohibited concomitant therapies.&#xD;
&#xD;
          -  Subjects with glomerular filtration rate (GFR) less than 45 ml/min/1.73 m2 as&#xD;
             determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)&#xD;
             creatinine equation.&#xD;
&#xD;
          -  Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt&#xD;
             of a transfusion of any blood product within 8 weeks prior to initial study drug&#xD;
             administration.&#xD;
&#xD;
          -  Consideration by the investigator for any reason that the subject is an unsuitable&#xD;
             candidate to receive ABBV-951.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Glendale Adventist Medical Ctr /ID# 166512</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinica Research - Orlando /ID# 169687</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acpru /Id# 154976</name>
      <address>
        <city>Grayslake</city>
        <state>Illinois</state>
        <zip>60030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Chandler Medical Center /ID# 169086</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parexel Baltimore /ID# 169255</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QUEST Research Institute /ID# 166035</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334-2977</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Phase I, LLC /ID# 166034</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>November 13, 2019</last_update_submitted>
  <last_update_submitted_qc>November 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2019</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>Parkinson Disease</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/NCT03033498
org study id: M15-738
nct id: NCT03033498
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of the study is to assess the safety, tolerability, and pharmacokinetics of
      single, ascending doses of ABBV-951 administered as a subcutaneous bolus infusion followed by
      a continuous subcutaneous infusion in subjects with Parkinson's disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Maximum Observed Plasma Concentration (Cmax) of Levodopa
time frame: Hour 0-24
description: Maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.
measure: Time to maximum observed plasma concentration (Tmax) of Levodopa
time frame: Hour 0-24
description: Time to maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.
measure: Area Under the Plasma Concentration-Time Curve (AUC) of Levodopa
time frame: Hour 0-24
description: Area under the plasma concentration-time curve following a single infusion of ABBV-951.
measure: Adverse Events
time frame: 24 hours
description: Number of participants reporting adverse events
measure: Terminal phase elimination rate constant (β)
time frame: Up to 72 hours
description: Apparent terminal phase elimination rate constant (β or Beta)
measure: Terminal phase elimination half-life (T1/2)
time frame: Up to 72 hours
description: Terminal phase elimination half-life (t1/2) will be assessed.
measure: Corrected QT (QTc) Interval
time frame: Up to 76 hours
description: QT interval adjusted for heart rate.
arm group label: ABBV-951 Dose 1
arm group type: Experimental
description: Participants will receive dose 1 of ABBV-951.
arm group label: ABBV-951 Dose 2
arm group type: Experimental
description: Participants will receive dose 2 of ABBV-951.
arm group label: ABBV-951 Dose 3
arm group type: Experimental
description: Participants will receive dose 3 of ABBV-951.
arm group label: ABBV-951 Dose 4
arm group type: Experimental
description: Participants will receive dose 4 of ABBV-951.
arm group label: ABBV-951 Dose 5
arm group type: Experimental
description: Participants will receive dose 5 of ABBV-951.
arm group label: ABBV-951 Dose 6
arm group type: Experimental
description: Participants will receive dose 6 of ABBV-951.
arm group label: ABBV-951 Dose 7
arm group type: Experimental
description: Participants will receive dose 7 of ABBV-951.
arm group label: ABBV-951 Dose 8
arm group type: Experimental
description: Participants will receive dose 8 of ABBV-951.
intervention type: Drug
intervention name: ABBV-951
description: ABBV-951 administered by subcutaneous infusion.
arm group label: ABBV-951 Dose 1
arm group label: ABBV-951 Dose 2
arm group label: ABBV-951 Dose 3
arm group label: ABBV-951 Dose 4
arm group label: ABBV-951 Dose 5
arm group label: ABBV-951 Dose 6
arm group label: ABBV-951 Dose 7
arm group label: ABBV-951 Dose 8
criteria: 
gender: All
minimum age: 45 Years
maximum age: 85 Years
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No