<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/NCT01692184</url>
  </required_header>
  <id_info>
    <org_study_id>AVL-292-004</org_study_id>
    <nct_id>NCT01692184</nct_id>
  </id_info>
  <brief_title>Safety and Pharmacokinetics of AVL-292 Following Multiple Doses and the Effect of Food on the Single-dose Pharmacokinetics of AVL-292</brief_title>
  <official_title>A Phase 1, Two-part Study to Investigate the Safety and Pharmacokinetics of AVL-292 Following Multiple Oral Doses and to Evaluate the Effect of Food on the Pharmacokinetics of AVL-292 Following a Single Oral Dose in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celgene</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and&#xD;
      pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate&#xD;
      the effect of food on the pharmacokinetics of a single oral dose of AVL-292.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part 2 is an open-label, randomized, 2-period, 2-way crossover study to evaluate the effect&#xD;
      of a standard high-fat breakfast on the pharmacokinetics of AVL-292. Ten subjects will be&#xD;
      enrolled to receive 2 single doses of 200 mg AVL-292, one with food (i.e., fed) and the other&#xD;
      without (i.e., fasted), in a randomized sequence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2012</start_date>
  <completion_date type="Actual">October 8, 2012</completion_date>
  <primary_completion_date type="Actual">October 8, 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>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Up to 28 days after last AVL-292 dose</time_frame>
    <description>Number of participants with adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK-(Cmax)</measure>
    <time_frame>24 hours after the last AVL-292 dose on days 1 and 7</time_frame>
    <description>Maximum observed concentration in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK-(AUC)</measure>
    <time_frame>24 hours after the last AVL-292 dose days 1 and 7</time_frame>
    <description>Area under the plasma concentration-time curve</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells</measure>
    <time_frame>24 hours after the last AVL-292 dose days 1 and 7</time_frame>
    <description>Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>50 mg of AVL-292 and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 mg AVL-292 (2 x 25 mg AVL-292 capsules and 6 placebo capsules) once daily for 7 days administered orally under fasted condition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>100 mg of AVL-292 and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 mg AVL-292 (4 x 25 mg AVL-292 capsules and 4 placebo capsules) once daily for 7 days administered orally under fasted condition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>200 mg AVL-292</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 x 25 mg AVL-292 capsules orally once daily for 7 days under fasted condition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>350 mg of AVL-292</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>350 mg AVL-292 (14 x 25 mg AVL-292 capsules) once daily for 7 days administered orally under fasted condition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - 8 capsules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>8 placebo capsules once daily for 7 days administered orally under fasted condition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - 14 capsules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>14 placebo capsules once daily for 7 days administered orally under fasted condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>50 mg AVL-292</intervention_name>
    <arm_group_label>50 mg of AVL-292 and Placebo</arm_group_label>
    <other_name>AVL-292</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>100 mg AVL-292</intervention_name>
    <arm_group_label>100 mg of AVL-292 and Placebo</arm_group_label>
    <other_name>AVL-292</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>200 mg AVL-292</intervention_name>
    <arm_group_label>200 mg AVL-292</arm_group_label>
    <other_name>AVL-292</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>350 mg AVL-292</intervention_name>
    <arm_group_label>350 mg of AVL-292</arm_group_label>
    <other_name>AVL-292</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo capsules</intervention_name>
    <arm_group_label>100 mg of AVL-292 and Placebo</arm_group_label>
    <arm_group_label>50 mg of AVL-292 and Placebo</arm_group_label>
    <arm_group_label>Placebo - 14 capsules</arm_group_label>
    <arm_group_label>Placebo - 8 capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female subjects of any ethnic origin between ages of 18 and 65 with a&#xD;
             body mass index between 18 and 33&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent history (i.e., within 3 years) of any clinically significant neurological,&#xD;
             gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine,&#xD;
             hematological, dermatological, psychological, ophthalmological, allergic or other&#xD;
             major disorders;&#xD;
&#xD;
          -  Use of any prescribed systemic or topical medication within 30 days of the first dose;&#xD;
&#xD;
          -  Use of any non-prescribed systemic or topical medication (including vitamin/mineral&#xD;
             supplements and herbal medicines, e.g., St. John's Wort) within 7 days of the first&#xD;
             dose administration;&#xD;
&#xD;
          -  Exposure to an investigational drug (new chemical entity) within 30 days prior to the&#xD;
             first dose administration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Palmisano, MD</last_name>
    <role>Study Director</role>
    <affiliation>Celgene Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Unit</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75247</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>October 31, 2019</last_update_submitted>
  <last_update_submitted_qc>October 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AVL-292</keyword>
  <keyword>Safety</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Pharmacodynamics</keyword>
  <keyword>Pharmacology, Clinical</keyword>
  <!-- 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/NCT01692184
org study id: AVL-292-004
nct id: NCT01692184
lead sponsor: 
has dmc: No
This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and
      pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate
      the effect of food on the pharmacokinetics of a single oral dose of AVL-292.
Part 2 is an open-label, randomized, 2-period, 2-way crossover study to evaluate the effect
      of a standard high-fat breakfast on the pharmacokinetics of AVL-292. Ten subjects will be
      enrolled to receive 2 single doses of 200 mg AVL-292, one with food (i.e., fed) and the other
      without (i.e., fasted), in a randomized sequence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse Events
time frame: Up to 28 days after last AVL-292 dose
description: Number of participants with adverse events
measure: PK-(Cmax)
time frame: 24 hours after the last AVL-292 dose on days 1 and 7
description: Maximum observed concentration in plasma
measure: PK-(AUC)
time frame: 24 hours after the last AVL-292 dose days 1 and 7
description: Area under the plasma concentration-time curve
measure: Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells
time frame: 24 hours after the last AVL-292 dose days 1 and 7
description: Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells
arm group label: 50 mg of AVL-292 and Placebo
arm group type: Experimental
description: 50 mg AVL-292 (2 x 25 mg AVL-292 capsules and 6 placebo capsules) once daily for 7 days administered orally under fasted condition
arm group label: 100 mg of AVL-292 and Placebo
arm group type: Experimental
description: 100 mg AVL-292 (4 x 25 mg AVL-292 capsules and 4 placebo capsules) once daily for 7 days administered orally under fasted condition
arm group label: 200 mg AVL-292
arm group type: Experimental
description: 8 x 25 mg AVL-292 capsules orally once daily for 7 days under fasted condition
arm group label: 350 mg of AVL-292
arm group type: Experimental
description: 350 mg AVL-292 (14 x 25 mg AVL-292 capsules) once daily for 7 days administered orally under fasted condition
arm group label: Placebo - 8 capsules
arm group type: Placebo Comparator
description: 8 placebo capsules once daily for 7 days administered orally under fasted condition
arm group label: Placebo - 14 capsules
arm group type: Placebo Comparator
description: 14 placebo capsules once daily for 7 days administered orally under fasted condition
intervention type: Drug
intervention name: 50 mg AVL-292
arm group label: 50 mg of AVL-292 and Placebo
other name: AVL-292
intervention type: Drug
intervention name: 100 mg AVL-292
arm group label: 100 mg of AVL-292 and Placebo
other name: AVL-292
intervention type: Drug
intervention name: 200 mg AVL-292
arm group label: 200 mg AVL-292
other name: AVL-292
intervention type: Drug
intervention name: 350 mg AVL-292
arm group label: 350 mg of AVL-292
other name: AVL-292
intervention type: Drug
intervention name: Placebo capsules
arm group label: 100 mg of AVL-292 and Placebo
arm group label: 50 mg of AVL-292 and Placebo
arm group label: Placebo - 14 capsules
arm group label: Placebo - 8 capsules
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Palmisano, MD
role: Study Director
affiliation: Celgene Corporation
facility: 
country: United States
responsible party type: Sponsor