<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/NCT01686217</url>
  </required_header>
  <id_info>
    <org_study_id>015K-CL-PK51</org_study_id>
    <nct_id>NCT01686217</nct_id>
  </id_info>
  <brief_title>A Phase I Study to Compare 3 Different Strengths of an Extended Release Formulation of ASP015K to an Immediate Release Formulation of ASP015K</brief_title>
  <official_title>A Phase 1, Open-Label, Randomized, Parallel Dose Group Study to Compare the Pharmacokinetic Profiles of Three Different Strengths of ASP015K Extended Release Formulation With ASP015K Immediate Release Formulation and to Evaluate Food Effect on Extended Release Strengths in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Global Development, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the pharmacokinetics (PK) profiles of three different&#xD;
      strengths of ASP015K extended release formulation and an immediate release formulation and to&#xD;
      evaluate food effect on extended release strengths in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study involves 3 parallel groups. Subjects in each group will receive 3 single-dose&#xD;
      treatments with a washout period of at least 7 days separating the dosing between two&#xD;
      consecutive treatments. Dosing conditions include both fed and fasted conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic (PK) for ASP015K (in plasma): Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf)</measure>
    <time_frame>Day 1-4 of each of 3 dosing periods</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK for ASP015K (in plasma): AUC from time of dosing to last quantifiable concentration (AUClast)</measure>
    <time_frame>Days 1-4 of each of 3 dosing periods</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK for ASP015K (in plasma): Maximum concentration (Cmax)</measure>
    <time_frame>Days 1-4 of each of 3 dosing periods</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK profile for ASP015K (in plasma): tmax , t1/2 , Vz /F, and CL/F</measure>
    <time_frame>Day 1-4 of each of 3 dosing periods</time_frame>
    <description>Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 ), apparent volume of distribution (Vz /F), apparent body clearance after oral dosing (CL/F)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK profile for metabolites (in plasma): Cmax, AUClast, and AUCinf, tmax,t1/2</measure>
    <time_frame>Day 1-4 of each of 3 dosing periods</time_frame>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Pharmacokinetics of ASP015K</condition>
  <condition>Food Effect</condition>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Dose Group 1 Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lowest per tablet dose of ASP015K Extended Release (ER) tablets under fasted conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 1 Treatment B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medium per tablet dose ASP015K Immediate Release (IR) tablets under fasted conditions for comparison to lowest dose ER fasted conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 1 Treatment C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lowest per tablet dose of ASP015K ER tablets under fed conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 2 Treatment D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medium per tablet dose of ASP015K ER tablets under fasted conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 2 Treatment E</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medium per tablet dose of ASP015K IR tablets under fasted conditions for comparison to medium dose ER fasted conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 2 Treatment F</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medium per tablet dose of ASP015K ER tablets under fed conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 3 Treatment G</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Highest per tablet dose of ASP015K ER tablets under fasted conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 3 Treatment H</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medium per tablet dose of ASP015K IR tablets under fasted conditions for comparison to highest dose ER under fasted conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 3 Treatment I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Highest dose of ASP015K ER tablets under fed conditions</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP015K ER</intervention_name>
    <description>oral extended release (ER) at three dosing levels</description>
    <arm_group_label>Dose Group 1 Treatment A</arm_group_label>
    <arm_group_label>Dose Group 1 Treatment C</arm_group_label>
    <arm_group_label>Dose Group 2 Treatment D</arm_group_label>
    <arm_group_label>Dose Group 2 Treatment F</arm_group_label>
    <arm_group_label>Dose Group 3 Treatment G</arm_group_label>
    <arm_group_label>Dose Group 3 Treatment I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP015K IR</intervention_name>
    <description>oral immediate release (IR)</description>
    <arm_group_label>Dose Group 1 Treatment B</arm_group_label>
    <arm_group_label>Dose Group 2 Treatment E</arm_group_label>
    <arm_group_label>Dose Group 3 Treatment H</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2,&#xD;
             inclusive at Screening&#xD;
&#xD;
          -  If female, the subject is surgically sterile (with documentation provided by a&#xD;
             healthcare professional), or is post-menopausal (defined as at least 2 years since&#xD;
             last regular menstrual cycle and confirmatory follicle stimulating hormone (FSH) level&#xD;
             of ≥ 30 U/L at screening) and the subject is not pregnant as documented by a negative&#xD;
             serum pregnancy test at Screening and Day -1 and is not lactating&#xD;
&#xD;
          -  If male, the subject agrees to sexual abstinence, is surgically sterile (with&#xD;
             documentation provided by a healthcare professional) or is using a medically&#xD;
             acceptable method to prevent pregnancy and agrees to continue using this method during&#xD;
             the study and until 90 days after the last dose of study drug administration&#xD;
&#xD;
          -  Male subject must agree to not donate sperm during the study and until 90 days after&#xD;
             last dose of study drug administration&#xD;
&#xD;
          -  The subject's 12-lead electrocardiogram (ECG) is normal at Screening and Day -1 of&#xD;
             initial treatment period or, if abnormal, the abnormality is not clinically&#xD;
             significant as determined by the Investigator&#xD;
&#xD;
          -  The subject's clinical laboratory test results at Screening and Day -1 are within&#xD;
             normal limits unless the Investigator considers the abnormality to be &quot;not clinically&#xD;
             significant&quot;&#xD;
&#xD;
          -  The subject is medically healthy, with no clinically significant medical history or&#xD;
             abnormalities observed upon physical examination as determined by the Investigator&#xD;
&#xD;
          -  The subject is willing and able to comply with the study requirements&#xD;
&#xD;
          -  The subject must be capable of swallowing multiple tablets&#xD;
&#xD;
          -  The subject is able to consume the FDA high fat breakfast within 30 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has a previous history of any clinically significant gastro-intestinal,&#xD;
             neurological, renal, hepatic, pulmonary, metabolic, cardio-vascular, psychiatric,&#xD;
             endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin&#xD;
             cancer or any other medical condition that, in the Investigator's opinion, would&#xD;
             preclude participation in the study&#xD;
&#xD;
          -  The subject has had major GI surgery (such as colectomy, cholecystectomy, etc) which&#xD;
             may inhibit the absorption and/or metabolism of study drug&#xD;
&#xD;
          -  The subject has a history of consuming more than 14 units of alcoholic beverages per&#xD;
             week or has a history of alcoholism or drug/chemical/ substance abuse within past 2&#xD;
             years prior to Screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1&#xD;
             ounce of spirits)&#xD;
&#xD;
          -  The subject has a positive test for alcohol or drugs of abuse at Screening or Day -1&#xD;
&#xD;
          -  The subject has a positive cotinine test at Screening or Day -1&#xD;
&#xD;
          -  The subject has had treatment with prescription, non-prescription or complementary and&#xD;
             alternative medicines (CAM) within 14 days prior to Day -1 (of initial treatment&#xD;
             period) with the exception of stable hormone replacement therapy (HRT) and/or&#xD;
             occasional use of acetaminophen (up to a maximum of 2 g/day)&#xD;
&#xD;
          -  The subject has/had a symptomatic, viral, bacterial (including upper respiratory&#xD;
             infection), or fungal (non-cutaneous) infection within 1 week prior to Day -1&#xD;
&#xD;
          -  The subject has a positive test for hepatitis C antibody, or positive test for&#xD;
             hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody at&#xD;
             Screening&#xD;
&#xD;
          -  The subject has a history of the human immunodeficiency virus (HIV) antibody&#xD;
&#xD;
          -  The subject has a positive tuberculosis (TB) skin test, Quantiferon Gold test or&#xD;
             T-SPOT® test at Screening&#xD;
&#xD;
          -  The subject received any vaccine within 60 days prior to study drug administration&#xD;
&#xD;
          -  The subject has received an experimental agent within 30 days or five half-lives,&#xD;
             whichever is longer, prior to study drug administration&#xD;
&#xD;
          -  The subject has had any significant blood loss, donated one unit (450 mL) of blood or&#xD;
             more, or received a transfusion of any blood or blood products within 60 days or&#xD;
             donated plasma within 7 days prior to clinic admission on Day -1&#xD;
&#xD;
          -  The subject has an absolute neutrophil count (ANC) &lt; 2500 cells/mm3 or a CPK &gt; 1.5x&#xD;
             upper limit of normal at Screening and Day -1 of initial treatment period&#xD;
&#xD;
          -  The subject has smoked or has used tobacco-containing products and nicotine or&#xD;
             nicotine-containing products in the past six months prior to Screening&#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>Astellas Pharma Global Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parexel International</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2012</study_first_posted>
  <last_update_submitted>August 31, 2015</last_update_submitted>
  <last_update_submitted_qc>August 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ASP015K Extended Release</keyword>
  <keyword>ASP015K Immediate Release</keyword>
  <keyword>Food Effect</keyword>
  <keyword>Healthy Volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Niacinamide</mesh_term>
    <mesh_term>Peficitinib</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/NCT01686217
org study id: 015K-CL-PK51
nct id: NCT01686217
lead sponsor: 
has dmc: No
The purpose of this study is to compare the pharmacokinetics (PK) profiles of three different
      strengths of ASP015K extended release formulation and an immediate release formulation and to
      evaluate food effect on extended release strengths in healthy volunteers.
Study involves 3 parallel groups. Subjects in each group will receive 3 single-dose
      treatments with a washout period of at least 7 days separating the dosing between two
      consecutive treatments. Dosing conditions include both fed and fasted conditions.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Pharmacokinetic (PK) for ASP015K (in plasma): Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf)
time frame: Day 1-4 of each of 3 dosing periods
measure: PK for ASP015K (in plasma): AUC from time of dosing to last quantifiable concentration (AUClast)
time frame: Days 1-4 of each of 3 dosing periods
measure: PK for ASP015K (in plasma): Maximum concentration (Cmax)
time frame: Days 1-4 of each of 3 dosing periods
measure: PK profile for ASP015K (in plasma): tmax , t1/2 , Vz /F, and CL/F
time frame: Day 1-4 of each of 3 dosing periods
description: Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 ), apparent volume of distribution (Vz /F), apparent body clearance after oral dosing (CL/F)
measure: PK profile for metabolites (in plasma): Cmax, AUClast, and AUCinf, tmax,t1/2
time frame: Day 1-4 of each of 3 dosing periods
arm group label: Dose Group 1 Treatment A
arm group type: Experimental
description: Lowest per tablet dose of ASP015K Extended Release (ER) tablets under fasted conditions
arm group label: Dose Group 1 Treatment B
arm group type: Active Comparator
description: Medium per tablet dose ASP015K Immediate Release (IR) tablets under fasted conditions for comparison to lowest dose ER fasted conditions
arm group label: Dose Group 1 Treatment C
arm group type: Experimental
description: Lowest per tablet dose of ASP015K ER tablets under fed conditions
arm group label: Dose Group 2 Treatment D
arm group type: Experimental
description: Medium per tablet dose of ASP015K ER tablets under fasted conditions
arm group label: Dose Group 2 Treatment E
arm group type: Active Comparator
description: Medium per tablet dose of ASP015K IR tablets under fasted conditions for comparison to medium dose ER fasted conditions
arm group label: Dose Group 2 Treatment F
arm group type: Experimental
description: Medium per tablet dose of ASP015K ER tablets under fed conditions
arm group label: Dose Group 3 Treatment G
arm group type: Experimental
description: Highest per tablet dose of ASP015K ER tablets under fasted conditions
arm group label: Dose Group 3 Treatment H
arm group type: Active Comparator
description: Medium per tablet dose of ASP015K IR tablets under fasted conditions for comparison to highest dose ER under fasted conditions
arm group label: Dose Group 3 Treatment I
arm group type: Experimental
description: Highest dose of ASP015K ER tablets under fed conditions
intervention type: Drug
intervention name: ASP015K ER
description: oral extended release (ER) at three dosing levels
arm group label: Dose Group 1 Treatment A
arm group label: Dose Group 1 Treatment C
arm group label: Dose Group 2 Treatment D
arm group label: Dose Group 2 Treatment F
arm group label: Dose Group 3 Treatment G
arm group label: Dose Group 3 Treatment I
intervention type: Drug
intervention name: ASP015K IR
description: oral immediate release (IR)
arm group label: Dose Group 1 Treatment B
arm group label: Dose Group 2 Treatment E
arm group label: Dose Group 3 Treatment H
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Global Development
facility: 
country: United States
responsible party type: Sponsor
mesh term: Niacinamide
mesh term: Peficitinib