<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/NCT02234999</url>
  </required_header>
  <id_info>
    <org_study_id>CC-122-CP-003</org_study_id>
    <nct_id>NCT02234999</nct_id>
  </id_info>
  <brief_title>Radiolabeled Study of CC-122 in Healthy Subjects</brief_title>
  <official_title>A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of [14C]-CC-122 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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the metabolism and excretion of [14C]-CC-122 in healthy male subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, open-label study to evaluate the metabolism and excretion of&#xD;
      [14C]-CC-122 following a single oral dose of [14C]-CC-122 in healthy male subjects. It is&#xD;
      planned for 6 subjects to be enrolled; each subject will participate in a screening phase, a&#xD;
      baseline phase, a treatment phase, and a follow up phone call. Blood, urine and fecal samples&#xD;
      will be collected for analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2014</start_date>
  <completion_date type="Actual">October 8, 2014</completion_date>
  <primary_completion_date type="Actual">October 8, 2014</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>Other</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Total [14C]-radioactivity in biological matrices-Pharmacokinetics (PK)</measure>
    <time_frame>Up to 12 days</time_frame>
    <description>Biological matrices (whole blood, plasma, urine and feces) will be collected and analyzed for total [14C]-radioactivity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative excretion of total [14C]-radioactivity in urine and feces (PK)</measure>
    <time_frame>Up to 12 days</time_frame>
    <description>Urine and feces will be collected and analyzed for measurement of [14C]-radioactivity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total [14C]-radioactivity whole blood-to-plasma ratios: PK</measure>
    <time_frame>Up to 8 days</time_frame>
    <description>Blood samples will be collected and analyzed for measurement of [14C]-radioactivity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolite profiling/characterization in select biological matrices-PK</measure>
    <time_frame>Up to 12 dyas</time_frame>
    <description>Biological matrices (plasma, urine, and fecal samples) will be collected and select samples will undergo metabolite profiling/characterization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak (maximum) plasma concentration (Cmax) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate PK</measure>
    <time_frame>Up to 12 days</time_frame>
    <description>Blood samples will be collected and analyzed; Maximum observed plasma or whole blood concentration for up to 168 hours postdose will be calculated and reported as appropriate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate</measure>
    <time_frame>Up to 12 days</time_frame>
    <description>Blood samples will be collected and analyzed; Area under the concentration-time curve from time zero up to 168 hours postdose will be calculated and reported as appropriate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to maximum plasma concentration (Tmax) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate</measure>
    <time_frame>Up to 12 days</time_frame>
    <description>Blood samples will be collected and analyzed; Time to reach the observed maximum (peak) concentration will be calculated and reported as appropriate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal elimination half-life (t1/2) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate</measure>
    <time_frame>Up to 12 days</time_frame>
    <description>Blood samples will be collected and analyzed; Terminal half-life will be calculated and reported as appropriate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence, type, severity of adverse events (AE)</measure>
    <time_frame>Up to 28 days following dose; AEs will be collected and recorded from the time the subjects signs Informed Consent throughthe 28 day period following the of last dose of study drug</time_frame>
    <description>An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values regardless of etiology</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>3mg [14C]-CC-122 (Single Dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral capsule of 3mg [14C]-CC-122. given as a suspension under fasting conditions on Day 1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC-122</intervention_name>
    <description>3mg [14C]-CC-122 will be administered as a single dose</description>
    <arm_group_label>3mg [14C]-CC-122 (Single Dose)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Healthy adult male of any race and between 18 years of age to 55 years of age,&#xD;
             inclusive, at the time of signing the informed consent document.&#xD;
&#xD;
             2. Understand and voluntarily sign an informed consent document before any study&#xD;
             related assessments/procedures are performed.&#xD;
&#xD;
             3. Able to adhere to the study visit schedule and other protocol requirements. 4. Must&#xD;
             practice true abstinence or agree to use a condom (a latex condom is recommended)&#xD;
             during sexual contact with a pregnant female or a female of childbearing potential&#xD;
             while participating in the study and for at least 28 days following discontinuation of&#xD;
             investigational product, even if he has undergone a successful vasectomy.&#xD;
&#xD;
             5. Must agree to abide by the CC 122 Pregnancy Prevention Risk Management Plan 6. Must&#xD;
             have a body mass index between 18 and 33 kg/m2, inclusive, at screening.&#xD;
&#xD;
             7. Must be healthy as determined by the Investigator on the basis of medical history,&#xD;
             physical exam, clinical laboratory test results, vital signs, and 12-lead&#xD;
             electrocardiogram at screening:&#xD;
&#xD;
               -  Must be afebrile (febrile is defined as ≥ 38.5°C or 101.3°F)&#xD;
&#xD;
               -  Supine systolic blood pressure must be in the range of 90 to 140 mmHg, supine&#xD;
                  diastolic blood pressure must be in the range of 50 to 90 mmHg, and pulse rate&#xD;
                  must be in the range of 40 to 110 bpm&#xD;
&#xD;
               -  Normal or clinically acceptable 12 lead electrocardiogram, with a QTcF value ≤&#xD;
                  430 msec&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. History of any clinically significant and relevant neurological, gastrointestinal,&#xD;
             renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine,&#xD;
             hematological, allergic disease, drug allergies (including a known hypersensitivity to&#xD;
             a member of the class of IMiDs®), or other major disorders.&#xD;
&#xD;
             2. Any condition, including the presence of clinically significant laboratory&#xD;
             abnormalities, which places the subject at unacceptable risk if he were to participate&#xD;
             in the study.&#xD;
&#xD;
             3. Any condition that confounds the ability to interpret data from the study. 4.&#xD;
             Exposed to an investigational drug (new chemical entity) within 30 days preceding dose&#xD;
             administration, or five half lives of that investigational drug, if known (whichever&#xD;
             is longer).&#xD;
&#xD;
             5. Participation in more than one other radiolabeled investigational drug study within&#xD;
             12 months prior to check in.&#xD;
&#xD;
        Note: The previous radiolabeled investigational drug must have been received more than 6&#xD;
        months prior to check in and the total planned exposure from this current study and the&#xD;
        previous study must be within the recommended levels considered safe, per United States&#xD;
        Code of Federal Regulations governing Protection of Human Subjects; radioactive drugs for&#xD;
        certain research uses.&#xD;
&#xD;
        6. Exposure to significant radiation (for example, serial X-ray or computed tomography&#xD;
        scans, barium meal, current employment in a job requiring radiation exposure monitoring)&#xD;
        within 12 months prior to check in.&#xD;
&#xD;
        7. Used any prescribed systemic or topical medication (including but not limited to&#xD;
        analgesics, anesthetics, etc) within 30 days of dose administration.&#xD;
&#xD;
        8. Used any nonprescribed systemic or topical medication (including vitamin/mineral&#xD;
        supplements, and herbal medicines) within 14 days of dose administration.&#xD;
&#xD;
        9. Used cytochrome P450 3A inducers and/or inhibitors (including St. John's wort) within 30&#xD;
        days of dose administration.&#xD;
&#xD;
        10. Received a live vaccination within 90 days of dose administration. 11. Has any surgical&#xD;
        or medical conditions possibly affecting absorption, distribution, metabolism, and/or&#xD;
        elimination, for example, bariatric procedure, or plans to have elective or medical&#xD;
        procedures performed during the conduct of the trial. Prior appendectomy is acceptable, but&#xD;
        prior cholecystectomy would result in exclusion from the study.&#xD;
&#xD;
        12. Donated blood or plasma within 8 weeks before dose administration to a blood bank or&#xD;
        blood donation center.&#xD;
&#xD;
        13. History of drug abuse (as defined by the current version of the Diagnostic and&#xD;
        Statistical Manual) within 2 years before dose administration, or positive drug screening&#xD;
        test reflecting consumption of illicit drugs.&#xD;
&#xD;
        14. History of alcohol abuse (as defined by the current version of the Diagnostic and&#xD;
        Statistical Manual) within 2 years before dose administration, or positive alcohol screen.&#xD;
&#xD;
        15. Known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen&#xD;
        or hepatitis C antibodies, or have a positive result to the test for HIV antibodies at&#xD;
        screening.&#xD;
&#xD;
        16. Smokes more than 10 cigarettes per day, or the equivalent in other tobacco products&#xD;
        (self reported).&#xD;
&#xD;
        17. Part of the clinical site staff personnel or family members of the clinical site staff.&#xD;
&#xD;
        18. History of less than one to two bowel movements per day.&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Edward O'Mara, MD</last_name>
    <role>Study Director</role>
    <affiliation>Celgene Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Unit Inc</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>November 2019</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>November 7, 2019</last_update_submitted>
  <last_update_submitted_qc>November 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacokinetics, Healthy Subjects</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/NCT02234999
org study id: CC-122-CP-003
nct id: NCT02234999
lead sponsor: 
has dmc: Yes
To evaluate the metabolism and excretion of [14C]-CC-122 in healthy male subjects
This is a single-center, open-label study to evaluate the metabolism and excretion of
      [14C]-CC-122 following a single oral dose of [14C]-CC-122 in healthy male subjects. It is
      planned for 6 subjects to be enrolled; each subject will participate in a screening phase, a
      baseline phase, a treatment phase, and a follow up phone call. Blood, urine and fecal samples
      will be collected for analyses.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
measure: Total [14C]-radioactivity in biological matrices-Pharmacokinetics (PK)
time frame: Up to 12 days
description: Biological matrices (whole blood, plasma, urine and feces) will be collected and analyzed for total [14C]-radioactivity
measure: Cumulative excretion of total [14C]-radioactivity in urine and feces (PK)
time frame: Up to 12 days
description: Urine and feces will be collected and analyzed for measurement of [14C]-radioactivity
measure: Total [14C]-radioactivity whole blood-to-plasma ratios: PK
time frame: Up to 8 days
description: Blood samples will be collected and analyzed for measurement of [14C]-radioactivity
measure: Metabolite profiling/characterization in select biological matrices-PK
time frame: Up to 12 dyas
description: Biological matrices (plasma, urine, and fecal samples) will be collected and select samples will undergo metabolite profiling/characterization
measure: Peak (maximum) plasma concentration (Cmax) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate PK
time frame: Up to 12 days
description: Blood samples will be collected and analyzed; Maximum observed plasma or whole blood concentration for up to 168 hours postdose will be calculated and reported as appropriate
measure: Area under the plasma concentration-time curve (AUC) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate
time frame: Up to 12 days
description: Blood samples will be collected and analyzed; Area under the concentration-time curve from time zero up to 168 hours postdose will be calculated and reported as appropriate
measure: Time to maximum plasma concentration (Tmax) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate
time frame: Up to 12 days
description: Blood samples will be collected and analyzed; Time to reach the observed maximum (peak) concentration will be calculated and reported as appropriate.
measure: Terminal elimination half-life (t1/2) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate
time frame: Up to 12 days
description: Blood samples will be collected and analyzed; Terminal half-life will be calculated and reported as appropriate
measure: The incidence, type, severity of adverse events (AE)
time frame: Up to 28 days following dose; AEs will be collected and recorded from the time the subjects signs Informed Consent throughthe 28 day period following the of last dose of study drug
description: An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values regardless of etiology
arm group label: 3mg [14C]-CC-122 (Single Dose)
arm group type: Experimental
description: Single oral capsule of 3mg [14C]-CC-122. given as a suspension under fasting conditions on Day 1
intervention type: Drug
intervention name: CC-122
description: 3mg [14C]-CC-122 will be administered as a single dose
arm group label: 3mg [14C]-CC-122 (Single Dose)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Edward O'Mara, MD
role: Study Director
affiliation: Celgene Corporation
facility: 
country: United States
responsible party type: Sponsor