<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/NCT03803644</url>
  </required_header>
  <id_info>
    <org_study_id>CC-92480-CP-001</org_study_id>
    <secondary_id>U1111-1224-6768</secondary_id>
    <nct_id>NCT03803644</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single Ascending Doses of CC-92480 in Healthy Subjects</brief_title>
  <official_title>A Phase 1, Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dosing of CC-92480 and to Explore the Effect of Food on the Bioavailability of CC-92480 in Healthy 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 two-part study to evaluate the safety, tolerability, pharmacokinetics and&#xD;
      pharmacodynamics of CC-92480 and explore the effect of food on the bioavailability of&#xD;
      CC-92480 in healthy subjects.&#xD;
&#xD;
      Part 1:&#xD;
&#xD;
      Part 1 is a single-center, randomized, double-blind, placebo-controlled study to evaluate the&#xD;
      safety, tolerability, PK, and pharmacodynamics (PD) of CC-92480 following administration of&#xD;
      single oral doses in healthy adult subjects. Part 1 will consist of escalating single doses&#xD;
      in sequential groups. Approximately 40 subjects will be enrolled into 5 planned dose level&#xD;
      cohorts. Each dose level cohort will consist of 8 subjects; 6 subjects will receive CC-92480&#xD;
      and 2 subjects will receive placebo according to the randomization schedule.&#xD;
&#xD;
      Part 2 Part 2 is a single-center, open-label, randomized, 2-period, 2-way crossover study to&#xD;
      explore the effect of food (Food and Drug Administration [FDA] standard high-fat breakfast)&#xD;
      on the single-dose PK of CC-92480 in healthy adult subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2018</start_date>
  <completion_date type="Actual">May 28, 2019</completion_date>
  <primary_completion_date type="Actual">May 28, 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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics- Cmax Part 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Maximum plasma concentration of drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics- Tmax Part 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Time to maximum plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics- AUC0-∞ Part 1</measure>
    <time_frame>Up to 72 hours after dose administration</time_frame>
    <description>Area under the plasma concentration-time curve from time zero extrapolated to infinity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics- AUC0-t Part 1</measure>
    <time_frame>Up to 72 hours after dose administration</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to the last quantifiable concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics- AUC0-24 Part 1</measure>
    <time_frame>Up to 24 hours after dose administration</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to 24 hours postdose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics- AUC-t½ Part 1</measure>
    <time_frame>Up to 72 hours after dose administration</time_frame>
    <description>Terminal half-life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics- CL/F Part 1</measure>
    <time_frame>Up to 72 hours after dose administration</time_frame>
    <description>Apparent total plasma clearance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics- Vz/F Part 1</measure>
    <time_frame>Up to 72 hours after dose administration</time_frame>
    <description>Apparent total volume of distribution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics- Cmax Part 2</measure>
    <time_frame>Day 1</time_frame>
    <description>Maximum plasma concentration of drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics- Tmax Part 2</measure>
    <time_frame>Day 1</time_frame>
    <description>Time to maximum plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics- AUC0-∞ Part 2</measure>
    <time_frame>Up to 72 hours after dose administration</time_frame>
    <description>Area under the plasma concentration-time curve from time zero extrapolated to infinity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics- AUC0-t Part 2</measure>
    <time_frame>Up to 72 hours after dose administration</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to the last quantifiable concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics- AUC0-24 Part 2</measure>
    <time_frame>Up to 24 hours after dose administration</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to 24 hours post dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics- AUC-t½ Part 2</measure>
    <time_frame>Up to 72 hours after dose administration</time_frame>
    <description>Terminal half-life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Event(s)</measure>
    <time_frame>From enrollment until at least 28 days after completion of study treatment</time_frame>
    <description>Number of participants with adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of CC-92480 on ECG parameters- Part 1</measure>
    <time_frame>Up to day 2</time_frame>
    <description>12-lead ECGs extracted from continuous (Holter) recordings will be used to assess effect of CC-92480 on Qt/QTc ECG parameters.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Administration of CC-92480 - Part 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dose escalation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Administration of CC-92480 under fasted conditions - Part 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Food effect</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Administration of CC-92480 under fed conditions - Part 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>food effect</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC-92480</intervention_name>
    <description>Part 1 dose escalation</description>
    <arm_group_label>Administration of CC-92480 - Part 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC-92480</intervention_name>
    <description>CC-92480</description>
    <arm_group_label>Administration of CC-92480 under fasted conditions - Part 2</arm_group_label>
    <arm_group_label>Administration of CC-92480 under fed conditions - Part 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects must satisfy the following criteria to be enrolled in the study:&#xD;
&#xD;
          1. Must understand and voluntarily sign a written informed consent form (ICF) prior to&#xD;
             any study-related assessments/procedures being performed.&#xD;
&#xD;
          2. Must be able to communicate with the Investigator, understand and comply with the&#xD;
             requirements of the study, and agree to adhere to restrictions and examination&#xD;
             schedules.&#xD;
&#xD;
          3. Be a healthy male or female of non-childbearing potential of any race, between 18 to&#xD;
             55 years of age (inclusive) at the time of signing the ICF, and in good health as&#xD;
             determined by the screening history and PE.&#xD;
&#xD;
          4. Agrees to abide by the requirements and restrictions outlined in the CC-92480&#xD;
             Pregnancy Prevention Plan for Subjects in Clinical Trials.&#xD;
&#xD;
          5. For males: Agree to use barrier contraception not made of natural (animal) membrane&#xD;
             (eg, latex or polyurethane condoms are acceptable) when engaging in sexual activity&#xD;
             with a female of childbearing potential (FCBP) 1 while on study medication, and for at&#xD;
             least 3 months after the last dose of study medication. For females: Female subjects&#xD;
             must have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper&#xD;
             documentation required) at least 6 months before screening, or be postmenopausal&#xD;
             (defined as 24 months without menses before screening, with a plasma&#xD;
             follicle-stimulation hormone [FSH] level of &gt; 40 IU/L at screening).&#xD;
&#xD;
          6. Must have a body mass index between 18 and 33 kg/m2 (inclusive) at the time of signing&#xD;
             the ICF.&#xD;
&#xD;
          7. No clinically significant laboratory test results as determined by the investigator.&#xD;
&#xD;
          8. At the screening visit, must be afebrile, with supine systolic BP: 90 to 140 mmHg,&#xD;
             supine diastolic BP: 50 to 90 mmHg, and pulse rate: 40 to 90 bpm. Eligibility criteria&#xD;
             for vital signs performed during check-in and/or predose on Day 1 will be at the&#xD;
             discretion of the Investigator. Repeat vital signs may be measured at Investigator&#xD;
             discretion.&#xD;
&#xD;
          9. Must have a normal or clinically-acceptable 12-lead ECG at screening. Male subjects&#xD;
             must have a corrected QT interval using Fridericia's formula (QTcF) value ≤ 430 msec.&#xD;
             Female subjects must have a QTcF value ≤ 450 msec.&#xD;
&#xD;
         10. Subject must agree and be willing to consume a standard high-fat meal (which may&#xD;
             contain gluten), for Part 2 subjects only.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The presence of any of the following will exclude a subject from enrollment:&#xD;
&#xD;
          1. History of any clinically significant and relevant neurological, GI, renal, hepatic,&#xD;
             cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological,&#xD;
             allergic disease, drug allergies, or other major disorders as determined by the&#xD;
             Investigator.&#xD;
&#xD;
          2. Any condition that places the subject at unacceptable risk if he or she were to&#xD;
             participate in the study, or confounds the ability to interpret data from the study.&#xD;
&#xD;
          3. Use of any prescribed systemic or topical medication (including but not limited to&#xD;
             analgesics, anesthetics, etc) within 30 days of the first dose administration.&#xD;
&#xD;
          4. Use of any nonprescribed systemic or topical medication (including vitamin/mineral&#xD;
             supplements, and herbal medicines) within 14 days of the first dose administration.&#xD;
&#xD;
          5. Use of CYP3A inducers and inhibitors (including St. John's Wort) within 30 days of the&#xD;
             first dose administration.&#xD;
&#xD;
          6. Has any surgical or medical conditions possibly affecting drug absorption,&#xD;
             distribution, metabolism and excretion (ADME), eg, bariatric procedure. Appendectomy&#xD;
             and cholecystectomy are acceptable. Prior procedures of unclear ADME significance&#xD;
             should be reviewed with the Sponsor's Medical Monitor.&#xD;
&#xD;
          7. Donated blood or plasma within 8 weeks before the first dose administration to a blood&#xD;
             bank or blood donation center.&#xD;
&#xD;
          8. History of drug abuse (as defined by the current version of the Diagnostic and&#xD;
             Statistical Manual [DSM]) within 2 years before dosing, or positive drug screening&#xD;
             test reflecting consumption of illicit drugs.&#xD;
&#xD;
          9. History of alcohol abuse (as defined by the current version of the DSM) within 2 years&#xD;
             before dosing, or positive alcohol screen.&#xD;
&#xD;
         10. Known to have serum hepatitis; known to be a carrier of the hepatitis B surface&#xD;
             antigen (HBsAg), hepatitis B surface antibody (anti-HBs), hepatitis B core antibody&#xD;
             (anti-HBc), or hepatitis C antibody (HCV Ab); have a positive result to the test for&#xD;
             hepatitis B or hepatitis C virus at screening or have a positive result to the test&#xD;
             for human immunodeficiency virus (HIV) antibodies at screening. Subjects whose results&#xD;
             are compatible with prior immunization against hepatitis B may be included at the&#xD;
             discretion of the Investigator.&#xD;
&#xD;
         11. Exposure to an investigational drug (new chemical entity) within 30 days preceding the&#xD;
             first dose administration, or 5 half-lives of that investigational drug, if known&#xD;
             (whichever is longer).&#xD;
&#xD;
         12. Use of tobacco- or nicotine-containing products within 3 months prior to Day -1&#xD;
             (Period 1 for Part 2).&#xD;
&#xD;
         13. Vaccination within 30 days of dosing or plans to receive vaccination within 30 days&#xD;
             after dosing.&#xD;
&#xD;
         14. Systemic infection within 30 days of dosing.&#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>Leon Carayannopoulos, MD</last_name>
    <role>Study Director</role>
    <affiliation>Celgene</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance-Daytona Beach</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>May 6, 2020</last_update_submitted>
  <last_update_submitted_qc>May 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Subjects</keyword>
  <keyword>CC-92480</keyword>
  <keyword>Food Effect</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/NCT03803644
org study id: CC-92480-CP-001
secondary id: U1111-1224-6768
nct id: NCT03803644
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a two-part study to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of CC-92480 and explore the effect of food on the bioavailability of
      CC-92480 in healthy subjects.

      Part 1:

      Part 1 is a single-center, randomized, double-blind, placebo-controlled study to evaluate the
      safety, tolerability, PK, and pharmacodynamics (PD) of CC-92480 following administration of
      single oral doses in healthy adult subjects. Part 1 will consist of escalating single doses
      in sequential groups. Approximately 40 subjects will be enrolled into 5 planned dose level
      cohorts. Each dose level cohort will consist of 8 subjects; 6 subjects will receive CC-92480
      and 2 subjects will receive placebo according to the randomization schedule.

      Part 2 Part 2 is a single-center, open-label, randomized, 2-period, 2-way crossover study to
      explore the effect of food (Food and Drug Administration [FDA] standard high-fat breakfast)
      on the single-dose PK of CC-92480 in healthy adult subjects.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pharmacokinetics- Cmax Part 1
time frame: Day 1
description: Maximum plasma concentration of drug
measure: Pharmacokinetics- Tmax Part 1
time frame: Day 1
description: Time to maximum plasma concentration
measure: Pharmacokinetics- AUC0-∞ Part 1
time frame: Up to 72 hours after dose administration
description: Area under the plasma concentration-time curve from time zero extrapolated to infinity
measure: Pharmacokinetics- AUC0-t Part 1
time frame: Up to 72 hours after dose administration
description: Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
measure: Pharmacokinetics- AUC0-24 Part 1
time frame: Up to 24 hours after dose administration
description: Area under the plasma concentration-time curve from time zero to 24 hours postdose
measure: Pharmacokinetics- AUC-t½ Part 1
time frame: Up to 72 hours after dose administration
description: Terminal half-life
measure: Pharmacokinetics- CL/F Part 1
time frame: Up to 72 hours after dose administration
description: Apparent total plasma clearance
measure: Pharmacokinetics- Vz/F Part 1
time frame: Up to 72 hours after dose administration
description: Apparent total volume of distribution
measure: Pharmacokinetics- Cmax Part 2
time frame: Day 1
description: Maximum plasma concentration of drug
measure: Pharmacokinetics- Tmax Part 2
time frame: Day 1
description: Time to maximum plasma concentration
measure: Pharmacokinetics- AUC0-∞ Part 2
time frame: Up to 72 hours after dose administration
description: Area under the plasma concentration-time curve from time zero extrapolated to infinity
measure: Pharmacokinetics- AUC0-t Part 2
time frame: Up to 72 hours after dose administration
description: Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
measure: Pharmacokinetics- AUC0-24 Part 2
time frame: Up to 24 hours after dose administration
description: Area under the plasma concentration-time curve from time zero to 24 hours post dose
measure: Pharmacokinetics- AUC-t½ Part 2
time frame: Up to 72 hours after dose administration
description: Terminal half-life
measure: Adverse Event(s)
time frame: From enrollment until at least 28 days after completion of study treatment
description: Number of participants with adverse events
measure: Effect of CC-92480 on ECG parameters- Part 1
time frame: Up to day 2
description: 12-lead ECGs extracted from continuous (Holter) recordings will be used to assess effect of CC-92480 on Qt/QTc ECG parameters.
arm group label: Administration of CC-92480 - Part 1
arm group type: Experimental
description: dose escalation
arm group label: Administration of CC-92480 under fasted conditions - Part 2
arm group type: Experimental
description: Food effect
arm group label: Administration of CC-92480 under fed conditions - Part 2
arm group type: Experimental
description: food effect
intervention type: Drug
intervention name: CC-92480
description: Part 1 dose escalation
arm group label: Administration of CC-92480 - Part 1
intervention type: Drug
intervention name: CC-92480
description: CC-92480
arm group label: Administration of CC-92480 under fasted conditions - Part 2
arm group label: Administration of CC-92480 under fed conditions - Part 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Leon Carayannopoulos, MD
role: Study Director
affiliation: Celgene
facility: 
country: United States
responsible party type: Sponsor