<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/NCT03294603</url>
  </required_header>
  <id_info>
    <org_study_id>CC-220-CP-006</org_study_id>
    <secondary_id>U1111-1202-3955</secondary_id>
    <nct_id>NCT03294603</nct_id>
  </id_info>
  <brief_title>Radiolabeled Study of CC-220 in Healthy Male Subjects</brief_title>
  <official_title>A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of (14C)-CC-220 in Healthy Male 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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-center, open-label study to characterize the biotransformation and excretion&#xD;
      of [14C]-CC-220 in healthy male subjects. Each subject will participate in screening, a&#xD;
      treatment phase (including baseline), and a follow-up phone call. Subjects will be screened&#xD;
      for eligibility. Subjects who have met all inclusion criteria and none of the exclusion&#xD;
      criteria at screening will return to the study site on Day -1, and will be domiciled at the&#xD;
      study site from Day -1 to Day 10. On Day 1, subjects will receive a single oral dose of 1 mg&#xD;
      [14C]-CC-220 under fasted conditions. Blood, urine, and fecal samples will be collected&#xD;
      throughout the study for pharmacokinetic (PK; inclusive of metabolite profiling /&#xD;
      characterization), mass balance, and/or clinical laboratory assessments. Safety will be&#xD;
      monitored throughout the study. Subjects will be discharged from the study site on Day 10&#xD;
      following completion of the scheduled study procedures and satisfactory safety review.&#xD;
      Subjects will participate in a follow-up phone call within 5 to 7 days following discharge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">October 16, 2017</completion_date>
  <primary_completion_date type="Actual">October 16, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics -Total [14C]-Radioactivity (RA)</measure>
    <time_frame>Up to approximately Day 10</time_frame>
    <description>Total [14C]-RA in whole blood, plasma, urine, and feces (and vomit, if applicable) will be measured via AMS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics - Cumulative excretion of total [14C]-RA</measure>
    <time_frame>Up to approximately Day 10</time_frame>
    <description>Total RA recovery will be computed as the sum of the cumulative excretion (as % dose) in urine and feces (and vomit, if applicable).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics - Total [14C]-RA whole blood-to-plasma</measure>
    <time_frame>Up to approximately Day 10</time_frame>
    <description>Total [14C]-RA in whole blood and plasma will be converted to ngEq/mL concentration of [14C]-CC-220 based on specific activity of the dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics - metabolite profiling/characterization</measure>
    <time_frame>Up to approximately Day 10</time_frame>
    <description>Percentage of the administered dose attributed to CC-220 and metabolite(s), and the RA of [14C]-CC-220 and metabolite(s), as appropriate, will be estimated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics -Cmax</measure>
    <time_frame>Up to approximately Day 10</time_frame>
    <description>Observed maximum plasma concentration, provided sufficient data available</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics -AUC</measure>
    <time_frame>Up to approximately Day 10</time_frame>
    <description>Area under the concentration-time curve, provided sufficient data available</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics -Tmax</measure>
    <time_frame>Up to approximately Day 10</time_frame>
    <description>Time to Cmax, provided sufficient data available</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics -t1/2</measure>
    <time_frame>Up to approximately Day 10</time_frame>
    <description>Terminal elimination half-life, provided sufficient data available</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events (AEs)</measure>
    <time_frame>From enrollment until at least 28 days after completion of study treatment</time_frame>
    <description>Number of participants with adverse event</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>[14C]-CC-220 solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single oral dose of 1 mg [14C]-CC-220 solution, containing approximately 1.4 μCi of radioactivity, will be administered on Day 1 under fasted conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC-220</intervention_name>
    <description>1mg [14C]-CC-220 will be administered as a single dose</description>
    <arm_group_label>[14C]-CC-220 solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>[14C]</intervention_name>
    <description>Single dose of [14C]-CC-220 will contain approximately 1.4 μCi of radioactivity</description>
    <arm_group_label>[14C]-CC-220 solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form&#xD;
             (ICF).&#xD;
&#xD;
          2. Subject is male.&#xD;
&#xD;
          3. Subject must understand and voluntarily sign an ICF prior to any study-related&#xD;
             assessments/procedures being conducted.&#xD;
&#xD;
          4. Subject is willing and able to adhere to the study visit schedule and other protocol&#xD;
             requirements.&#xD;
&#xD;
          5. Subject is in good health, as determined by the Investigator based on a physical&#xD;
             examination at screening.&#xD;
&#xD;
          6. Subject agrees to abide by the requirements and restrictions outlined in the CC-220&#xD;
             Pregnancy Prevention Plan for Subjects in Clinical Trials.&#xD;
&#xD;
          7. Subject must agree to use a barrier method of birth control (condoms not made out of&#xD;
             natural [animal] membrane [latex condoms are recommended]) during sexual contact with&#xD;
             a pregnant female or a female of childbearing potential (FCBP)1 while participating in&#xD;
             the study and for at least 90 days following administration of CC-220, even if he has&#xD;
             undergone a successful vasectomy.&#xD;
&#xD;
          8. Subject has a body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.&#xD;
&#xD;
          9. Subject has clinical laboratory safety test results that are within normal limits or&#xD;
             considered not clinically significant by the Investigator. Platelet count, absolute&#xD;
             neutrophil count (ANC), and absolute lymphocyte count (ALC) must be above the lower&#xD;
             limit of normal at screening.&#xD;
&#xD;
         10. Subject is afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg,&#xD;
             supine diastolic BP ≥ 50 and ≤ 90 mmHg, and pulse rate ≥ 40 and ≤ 110 bpm at&#xD;
             screening.&#xD;
&#xD;
         11. Subject has a normal or clinically acceptable 12-lead electrocardiogram (ECG), with a&#xD;
             QTcF value ≤ 430 msec, at screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has any significant medical condition, laboratory abnormality, or psychiatric&#xD;
             illness that would prevent the subject from participating in the study.&#xD;
&#xD;
          2. Subject has any condition including the presence of laboratory abnormalities, which&#xD;
             places the subject at unacceptable risk if he were to participate in the study.&#xD;
&#xD;
          3. Subject has any condition that confounds the ability to interpret data from the study.&#xD;
&#xD;
          4. Subject was exposed to an investigational drug (new chemical entity) within 30 days&#xD;
             prior to dosing, or 5 half-lives of that investigational drug, if known (whichever is&#xD;
             longer).&#xD;
&#xD;
          5. Subject has used any prescribed systemic or topical medication (including but not&#xD;
             limited to analgesics, anesthetics, etc) within 14 days or 5 half-lives of that&#xD;
             medication, whichever is longer, prior to dosing.&#xD;
&#xD;
          6. Subject has used any non-prescribed systemic or topical medication (including&#xD;
             vitamin/mineral supplements and herbal medicines) within 7 days prior to dosing.&#xD;
&#xD;
          7. Subject has used CYP3A inducers and/or inhibitors (including St. John's Wort) within&#xD;
             30 days prior to dosing. The Indiana University &quot;Cytochrome P450 Drug Interaction&#xD;
             Table&quot; should be utilized to determine inducers and/or inhibitors of CYP3A.&#xD;
&#xD;
          8. Subject has any surgical or medical conditions possibly affecting drug absorption,&#xD;
             distribution, metabolism, and excretion, eg, bariatric procedure.&#xD;
&#xD;
             Note: prior appendectomy is acceptable, but prior cholecystectomy would result in&#xD;
             exclusion from the study.&#xD;
&#xD;
          9. Subject donated blood or plasma within 8 weeks prior to dosing to a blood bank or&#xD;
             blood donation center.&#xD;
&#xD;
         10. Subject has a history of drug abuse (as defined by the current version of the&#xD;
             Diagnostic and Statistical Manual [DSM]) within 2 years prior to dosing, or positive&#xD;
             drug test reflecting consumption of illicit drugs.&#xD;
&#xD;
         11. Subject has a history of alcohol abuse (as defined by the current version of the DSM)&#xD;
             within 2 years prior to dosing, or positive alcohol test.&#xD;
&#xD;
         12. Subject is known to have serum hepatitis or known to be a carrier of hepatitis B&#xD;
             surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have a positive result to&#xD;
             the test for human immunodeficiency virus (HIV) antibodies at screening.&#xD;
&#xD;
         13. Subject smokes &gt; 10 cigarettes per day, or equivalent in other tobacco products&#xD;
             (self-reported).&#xD;
&#xD;
         14. Subject has received immunization with a live or live attenuated vaccine within 2&#xD;
             months prior to dosing or is planning to receive immunization with a live or live&#xD;
             attenuated vaccine for 2 months following dosing.&#xD;
&#xD;
         15. Subject participated in a radiolabeled drug study, where exposures are known to the&#xD;
             Investigator, within the previous 4 months prior to check-in (Day -1); or participated&#xD;
             in a radiolabeled drug study, where exposures are not known to the Investigator,&#xD;
             within the previous 6 months prior to check-in (Day -1). The total 12-month exposure&#xD;
             from this study and a maximum of 2 other previous studies within 4 to 12 months of&#xD;
             this study will be within the CFR recommended levels considered safe, per US Title 21&#xD;
             CFR 361.1: less than 5,000 mrem whole body annual exposure, with consideration given&#xD;
             to the half-lives of the previous radiolabeled study drugs received.&#xD;
&#xD;
         16. Subject was exposed to significant radiation (eg, serial X-ray or computed tomography&#xD;
             scans, barium meal, current employment in a job requiring radiation exposure&#xD;
             monitoring) within 12 months prior to check-in (Day -1).&#xD;
&#xD;
         17. History of less than 1 to 2 bowel movements per day.&#xD;
&#xD;
         18. Subject is part of the study site personnel or a family member of the study site&#xD;
             staff.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 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</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Unit</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Volunteer</keyword>
  <keyword>CC-220</keyword>
  <keyword>Male</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/NCT03294603
org study id: CC-220-CP-006
secondary id: U1111-1202-3955
nct id: NCT03294603
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a single-center, open-label study to characterize the biotransformation and excretion
      of [14C]-CC-220 in healthy male subjects. Each subject will participate in screening, a
      treatment phase (including baseline), and a follow-up phone call. Subjects will be screened
      for eligibility. Subjects who have met all inclusion criteria and none of the exclusion
      criteria at screening will return to the study site on Day -1, and will be domiciled at the
      study site from Day -1 to Day 10. On Day 1, subjects will receive a single oral dose of 1 mg
      [14C]-CC-220 under fasted conditions. Blood, urine, and fecal samples will be collected
      throughout the study for pharmacokinetic (PK; inclusive of metabolite profiling /
      characterization), mass balance, and/or clinical laboratory assessments. Safety will be
      monitored throughout the study. Subjects will be discharged from the study site on Day 10
      following completion of the scheduled study procedures and satisfactory safety review.
      Subjects will participate in a follow-up phone call within 5 to 7 days following discharge.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetics -Total [14C]-Radioactivity (RA)
time frame: Up to approximately Day 10
description: Total [14C]-RA in whole blood, plasma, urine, and feces (and vomit, if applicable) will be measured via AMS.
measure: Pharmacokinetics - Cumulative excretion of total [14C]-RA
time frame: Up to approximately Day 10
description: Total RA recovery will be computed as the sum of the cumulative excretion (as % dose) in urine and feces (and vomit, if applicable).
measure: Pharmacokinetics - Total [14C]-RA whole blood-to-plasma
time frame: Up to approximately Day 10
description: Total [14C]-RA in whole blood and plasma will be converted to ngEq/mL concentration of [14C]-CC-220 based on specific activity of the dose.
measure: Pharmacokinetics - metabolite profiling/characterization
time frame: Up to approximately Day 10
description: Percentage of the administered dose attributed to CC-220 and metabolite(s), and the RA of [14C]-CC-220 and metabolite(s), as appropriate, will be estimated.
measure: Pharmacokinetics -Cmax
time frame: Up to approximately Day 10
description: Observed maximum plasma concentration, provided sufficient data available
measure: Pharmacokinetics -AUC
time frame: Up to approximately Day 10
description: Area under the concentration-time curve, provided sufficient data available
measure: Pharmacokinetics -Tmax
time frame: Up to approximately Day 10
description: Time to Cmax, provided sufficient data available
measure: Pharmacokinetics -t1/2
time frame: Up to approximately Day 10
description: Terminal elimination half-life, provided sufficient data available
measure: Adverse Events (AEs)
time frame: From enrollment until at least 28 days after completion of study treatment
description: Number of participants with adverse event
arm group label: [14C]-CC-220 solution
arm group type: Experimental
description: A single oral dose of 1 mg [14C]-CC-220 solution, containing approximately 1.4 μCi of radioactivity, will be administered on Day 1 under fasted conditions.
intervention type: Drug
intervention name: CC-220
description: 1mg [14C]-CC-220 will be administered as a single dose
arm group label: [14C]-CC-220 solution
intervention type: Radiation
intervention name: [14C]
description: Single dose of [14C]-CC-220 will contain approximately 1.4 μCi of radioactivity
arm group label: [14C]-CC-220 solution
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Palmisano, MD
role: Study Director
affiliation: Celgene
facility: 
country: United States
responsible party type: Sponsor