<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/NCT02994381</url>
  </required_header>
  <id_info>
    <org_study_id>RPC01-1909</org_study_id>
    <nct_id>NCT02994381</nct_id>
  </id_info>
  <brief_title>A Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults</brief_title>
  <official_title>A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults</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 will be an open-label, non-randomized, single oral dose study in healthy male subjects.&#xD;
&#xD;
      All subjects will receive a single oral dose of 10 mL of [14C]-RPC1063 Solution (0.1 mg/mL),&#xD;
      containing NMT 1.3 MBq (37 μCi) 14C.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be screened for eligibility to participate in the study up to 28 days before&#xD;
      dosing. Subjects will be admitted to the clinical unit on the morning of Day -1 prior to IMP&#xD;
      administration. Subjects will be dosed on the morning of Day 1 following a standard&#xD;
      breakfast, and will remain resident in the clinic until up to 168 h after dosing. It is&#xD;
      planned that subjects will be released as a group when all subjects have achieved a mass&#xD;
      balance cumulative recovery of &gt;90% or if &lt;1% of the dose administered has been collected in&#xD;
      urine and faeces within 2 separate, consecutive 24 h periods. This may be earlier than 168 h&#xD;
      post-dose but no sooner than 96 h post-dose. In this case, collection of all samples (blood,&#xD;
      urine and faeces) will be stopped and the subjects will undergo discharge assessments. If&#xD;
      this criteria has not been met by all subjects on Day 8, home collections of urine and faeces&#xD;
      may be requested at the discretion of the investigator for individual subjects. A follow-up&#xD;
      phone call will take place 5 to 10 days after discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Percentage of elimination of [14C]-RPC1063</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Total recovery of radioactivity in urine and feces expressed as a percentage of total radioactive dose in each 24 h interval and cumulatively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic- amount of drug excreted</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Cumulative amount of drug excreted unchanged in the drug in urine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic- Cmax</measure>
    <time_frame>Up to 8 days</time_frame>
    <description>Maximum observed concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic- Tmax</measure>
    <time_frame>Up to 8 days</time_frame>
    <description>Time at maximum observed concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic- AUC0-last</measure>
    <time_frame>Up to 8 days</time_frame>
    <description>Area under the curve from 0 time to last measurable concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic- AUC0-inf</measure>
    <time_frame>Up to 8 days</time_frame>
    <description>Area under the curve from 0 time extrapolated to infinity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic- λz</measure>
    <time_frame>Up to 8 days</time_frame>
    <description>Elimination rate constant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic- t1/2</measure>
    <time_frame>Up to 8 days</time_frame>
    <description>Terminal elimination half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic- CL/F</measure>
    <time_frame>Up to 8 days</time_frame>
    <description>Clearance, the apparent volume cleared of parent drug per unit time after extravascular administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic- Vz/F</measure>
    <time_frame>Up to 8 days</time_frame>
    <description>The apparent volume of distribution after extravascular administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic- CLr</measure>
    <time_frame>Up to 8 days</time_frame>
    <description>Renal clearance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events (AEs)</measure>
    <time_frame>Approximately 2 months</time_frame>
    <description>Number of participants with adverse events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>[14C]-RPC1063 Solution (0.1 g/mL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 mg; 10 mL [14C]-RPC1063 HCl oral dose containing NMT 1.3 MBq (37 μCi) 14C</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RPC1063</intervention_name>
    <arm_group_label>[14C]-RPC1063 Solution (0.1 g/mL)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is male&#xD;
&#xD;
          2. Subject is 30 to 65 years of age&#xD;
&#xD;
          3. Subject has a body weight of at least 50 kg; body mass index (BMI) of 18.0 to 32.0&#xD;
             kg/m2 or, if outside the range, considered not clinically significant by the&#xD;
             investigator&#xD;
&#xD;
          4. Subject is willing and able to communicate and participate in the whole study&#xD;
&#xD;
          5. Subject has regular bowel movements (average stool production ≥1 and ≤3 stools per&#xD;
             day)&#xD;
&#xD;
          6. Subject has suitable veins for multiple cannulation as assessed by the investigator at&#xD;
             screening&#xD;
&#xD;
          7. Subject is able to comprehend the informed consent form, provide written informed&#xD;
             consent, and able to comply with requirements of the study.&#xD;
&#xD;
          8. Subject agrees to use an adequate method of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has received any investigational medicinal product (IMP) in a clinical&#xD;
             research study within the previous 3 months&#xD;
&#xD;
          2. Subject is a study site employee or an immediate family member of a study site or&#xD;
             sponsor employee&#xD;
&#xD;
          3. Subject has a history of any drug or alcohol abuse in the past 2 years&#xD;
&#xD;
          4. Subject has regular alcohol consumption of &gt;21 units per week (1 unit = ½ pint beer,&#xD;
             25 mL of 40% spirit or a 125 mL glass of wine)&#xD;
&#xD;
          5. Subject is a current smoker or has smoked within the last 12 months; including&#xD;
             cigarettes, e-cigarettes and nicotine replacement products. Positive cotinine test&#xD;
             result at screening and admission&#xD;
&#xD;
          6. Subject has radiation exposure, including that from the present study, excluding&#xD;
             background radiation but including diagnostic x-rays and other medical exposures,&#xD;
             exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No&#xD;
             occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999,&#xD;
             shall participate in the study&#xD;
&#xD;
          7. Subjects has been enrolled in an absorption, distribution, metabolism and elimination&#xD;
             (ADME) study in the last 12 months&#xD;
&#xD;
          8. Subject has clinically significant abnormal biochemistry or haematology as judged by&#xD;
             the investigator&#xD;
&#xD;
          9. Subject has positive drugs of abuse test result&#xD;
&#xD;
         10. Subject has positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody&#xD;
             (HCV Ab) or human immunodeficiency virus (HIV) results&#xD;
&#xD;
         11. Subject has evidence of renal impairment at screening and admission, as indicated by&#xD;
             an estimated creatinine clearance (CLcr) of &lt;90 mL/min using the Cockcroft-Gault&#xD;
             equation&#xD;
&#xD;
         12. Subject has alanine aminotransferase (ALT) or aspartate aminotransferase (AST)&#xD;
             concentration &gt;1.25 × the ULN at screening&#xD;
&#xD;
         13. Subject has history of cardiovascular, renal, hepatic, chronic respiratory or&#xD;
             gastrointestinal disease as judged by the investigator&#xD;
&#xD;
         14. Subject has had serious adverse reaction or serious hypersensitivity to any drug or&#xD;
             the formulation excipients&#xD;
&#xD;
         15. Subject has presence or history of clinically significant allergy requiring treatment,&#xD;
             as judged by the investigator. Hayfever is allowed unless it is active&#xD;
&#xD;
         16. Subject has donated or lost greater than 400 mL of blood within the previous 3 months&#xD;
&#xD;
         17. Subject is taking, or has taken, any prescribed or over-the-counter drug (other than 2&#xD;
             g per 24 h paracetamol) dietary or herbal remedies within 14 days before IMP&#xD;
             administration, or has taken St. John's wort within 28 days before IMP administration.&#xD;
             Exceptions may apply on a case by case basis, if considered not to interfere with the&#xD;
             objectives of the study, as agreed by the PI and sponsor's medical monitor.&#xD;
&#xD;
         18. Subject fails to satisfy the investigator of fitness to participate for any other&#xD;
             reason&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Tran, Pharm.D</last_name>
    <role>Study Director</role>
    <affiliation>Celgene Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Clinical</name>
      <address>
        <city>Nottingham</city>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Male Adults</keyword>
  <keyword>14C</keyword>
  <keyword>RPC1063</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ozanimod</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/NCT02994381
org study id: RPC01-1909
nct id: NCT02994381
lead sponsor: 
has dmc: No
This will be an open-label, non-randomized, single oral dose study in healthy male subjects.

      All subjects will receive a single oral dose of 10 mL of [14C]-RPC1063 Solution (0.1 mg/mL),
      containing NMT 1.3 MBq (37 μCi) 14C.
Subjects will be screened for eligibility to participate in the study up to 28 days before
      dosing. Subjects will be admitted to the clinical unit on the morning of Day -1 prior to IMP
      administration. Subjects will be dosed on the morning of Day 1 following a standard
      breakfast, and will remain resident in the clinic until up to 168 h after dosing. It is
      planned that subjects will be released as a group when all subjects have achieved a mass
      balance cumulative recovery of >90% or if <1% of the dose administered has been collected in
      urine and faeces within 2 separate, consecutive 24 h periods. This may be earlier than 168 h
      post-dose but no sooner than 96 h post-dose. In this case, collection of all samples (blood,
      urine and faeces) will be stopped and the subjects will undergo discharge assessments. If
      this criteria has not been met by all subjects on Day 8, home collections of urine and faeces
      may be requested at the discretion of the investigator for individual subjects. A follow-up
      phone call will take place 5 to 10 days after discharge.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of elimination of [14C]-RPC1063
time frame: Up to 4 weeks
description: Total recovery of radioactivity in urine and feces expressed as a percentage of total radioactive dose in each 24 h interval and cumulatively
measure: Pharmacokinetic- amount of drug excreted
time frame: Up to 4 weeks
description: Cumulative amount of drug excreted unchanged in the drug in urine
measure: Pharmacokinetic- Cmax
time frame: Up to 8 days
description: Maximum observed concentration
measure: Pharmacokinetic- Tmax
time frame: Up to 8 days
description: Time at maximum observed concentration
measure: Pharmacokinetic- AUC0-last
time frame: Up to 8 days
description: Area under the curve from 0 time to last measurable concentration
measure: Pharmacokinetic- AUC0-inf
time frame: Up to 8 days
description: Area under the curve from 0 time extrapolated to infinity
measure: Pharmacokinetic- λz
time frame: Up to 8 days
description: Elimination rate constant
measure: Pharmacokinetic- t1/2
time frame: Up to 8 days
description: Terminal elimination half-life
measure: Pharmacokinetic- CL/F
time frame: Up to 8 days
description: Clearance, the apparent volume cleared of parent drug per unit time after extravascular administration
measure: Pharmacokinetic- Vz/F
time frame: Up to 8 days
description: The apparent volume of distribution after extravascular administration
measure: Pharmacokinetic- CLr
time frame: Up to 8 days
description: Renal clearance
measure: Adverse Events (AEs)
time frame: Approximately 2 months
description: Number of participants with adverse events
arm group label: [14C]-RPC1063 Solution (0.1 g/mL)
arm group type: Experimental
description: 1 mg; 10 mL [14C]-RPC1063 HCl oral dose containing NMT 1.3 MBq (37 μCi) 14C
intervention type: Drug
intervention name: RPC1063
arm group label: [14C]-RPC1063 Solution (0.1 g/mL)
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan Tran, Pharm.D
role: Study Director
affiliation: Celgene Corporation
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Ozanimod