xml: <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/NCT06004960</url>
    </required_header>
    <id_info>
      <org_study_id>CL004_168</org_study_id>
      <nct_id>NCT06004960</nct_id>
    </id_info>
    <brief_title>A Study to Assess the Mass Balance Recovery (Absorption, Distribution, Metabolism and Excretion) of [14C]CCX168 in Healthy Participants</brief_title>
    <official_title>An Open-Label, Phase 1 Study in Healthy Volunteers to Evaluate the Mass Balance Recovery and Metabolic Disposition of a Single Oral Dose of [14C]CCX168</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Amgen</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Amgen</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary objective of this study is to perform mass balance following a single oral dose&#xD;
        of [14C]CCX168 in healthy adult male participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 20, 2014</start_date>
    <completion_date type="Actual">December 5, 2014</completion_date>
    <primary_completion_date type="Actual">December 5, 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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Urine</measure>
      <time_frame>Up to Day 15</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Feces</measure>
      <time_frame>Up to Day 15</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum Observed Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of Occurrence of Maximum Observed Concentration (Tmax) of Total Radioactivity in Plasma and Whole Blood</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination Rate Constant (λz) of Total Radioactivity in Plasma and Whole Blood</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent Terminal Half-life (t½z) of Total Radioactivity in Plasma and Whole Blood</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent Total Clearance (CL/F) of Total Radioactivity in Plasma and Whole Blood</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent Volume of Distribution (Vz/F) of Total Radioactivity in Plasma and Whole Blood</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area Under the Concentration-Time Curve from Time 0 to Time t (AUC0-t) of Total Radioactivity in Plasma and Whole Blood</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of Total Radioactivity in Plasma and Whole Blood</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of Total Radioactivity in Plasma and Whole Blood</measure>
      <time_frame>Up to 24 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cmax of CCX168 and Metabolites in Plasma</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax of CCX168 and Metabolites in Plasma</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>λz of CCX168 and Metabolites in Plasma</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>t½z of CCX168 and Metabolites in Plasma</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CL/F of CCX168 and Metabolites in Plasma</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vz/F of CCX168 and Metabolites in Plasma</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC0-t of CCX168 and Metabolites in Plasma</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUCinf of CCX168 and Metabolites in Plasma</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC0-24 of CCX168 and Metabolites in Plasma</measure>
      <time_frame>Up to 24 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus</measure>
      <time_frame>Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus</measure>
      <time_frame>Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Amount of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus (Auinf + Afinf + Avinf)</measure>
      <time_frame>Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Amount of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus (Amxuinf + Amxfinf + Amxvinf)</measure>
      <time_frame>Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Renal Clearance (CLR) of [14C]CCX168</measure>
      <time_frame>Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Renal Clearance of [14C]-Metabolite (CLRmx)</measure>
      <time_frame>Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Adverse Events (AEs)</measure>
      <time_frame>Up to Day 29</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters</measure>
      <time_frame>Up to Day 29</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters</measure>
      <time_frame>Up to Day 29</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">6</enrollment>
    <condition>Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis</condition>
    <arm_group>
      <arm_group_label>[14C]CCX168</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single oral dose of [14C]CCX168 100 mg containing 400 μCi of [14C] on Day 1.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>[14C]CCX168</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>[14C]CCX168</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males, aged 18-55 years inclusive, who are in generally good health, whose body mass&#xD;
               index is 19.0 to 30.0 kg/m^2 inclusive;&#xD;
  &#xD;
            -  Willing and able to give written Informed Consent and to comply with the requirements&#xD;
               of the study protocol;&#xD;
  &#xD;
            -  Negative result of the human immunodeficiency virus screen, the hepatitis B screen,&#xD;
               and the hepatitis C screen;&#xD;
  &#xD;
            -  Judged to be healthy by the Investigator, based on medical history, physical&#xD;
               examination (including electrocardiogram), and clinical laboratory assessments.&#xD;
               Participants with clinical laboratory values that are outside of normal limits and/or&#xD;
               with other abnormal clinical findings that are judged by the Investigator not to be of&#xD;
               clinical significance may be entered into the study;&#xD;
  &#xD;
            -  Male participants with partners of childbearing potential may participate if adequate&#xD;
               contraception is used during, and for 90 days after, any administration of study&#xD;
               medication;&#xD;
  &#xD;
            -  Males must refrain from sperm donation for 90 days following completion of the study;&#xD;
  &#xD;
            -  Participants must have regular (at least once per day) bowel movements.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participated in any studies where any radiolabeled drug was administered in the year&#xD;
               prior to enrollment;&#xD;
  &#xD;
            -  Received a diagnostic or therapeutic radiation dose (such as a barium meal, serial&#xD;
               x-ray scan, or computed tomography scan) within 1 year of enrollment or are currently&#xD;
               employed in a job requiring radiation exposure monitoring;&#xD;
  &#xD;
            -  Expected requirement for use of any medication during the study period;&#xD;
  &#xD;
            -  For at least 3 days prior to enrollment and throughout the blood sample collection&#xD;
               period, participants will not be allowed to eat any food or drink any beverage&#xD;
               containing alcohol, caffeine, grapefruit, grapefruit juice, Seville oranges, or&#xD;
               charbroiled meat;&#xD;
  &#xD;
            -  History within the three months prior to study entry of use of tobacco and/or nicotine&#xD;
               containing products;&#xD;
  &#xD;
            -  History within one year prior to study entry of illicit drug use;&#xD;
  &#xD;
            -  History of alcohol abuse at any time in the past;&#xD;
  &#xD;
            -  History of any form of cancer;&#xD;
  &#xD;
            -  History or presence of any medical condition or disease which, in the opinion of the&#xD;
               Investigator, may place the participant at unacceptable risk for study participation;&#xD;
  &#xD;
            -  Donated or lost more than 350 mL of blood or blood products within 56 days prior to&#xD;
               screening, or donated plasma within 7 days of dosing;&#xD;
  &#xD;
            -  Participant's hemoglobin less than 12 g/dL, confirmed by repeat measurement;&#xD;
  &#xD;
            -  Participated in any clinical study of an investigational product within 30 days prior&#xD;
               to dosing;&#xD;
  &#xD;
            -  Participant has any evidence of hepatic disease; aspartate aminotransferase, alanine&#xD;
               aminotransferase, alkaline phosphatase, or bilirubin greater than the upper limit of&#xD;
               normal, unless considered not clinically significant by the Investigator;&#xD;
  &#xD;
            -  Participant's white blood cell count is below the lower limit of normal at Screening&#xD;
               or Check-in (Day -1), confirmed by repeat measurement;&#xD;
  &#xD;
            -  Participant has any evidence of renal impairment; serum creatinine greater than the&#xD;
               upper limit of normal, unless considered not clinically significant by the&#xD;
               investigator;&#xD;
  &#xD;
            -  Participant's urine tested positive at Screening and/or on Study Day -1 for any of the&#xD;
               following: opioids, amphetamines and methamphetamines, cannabinoids, benzodiazepines,&#xD;
               barbiturates, cocaine, cotinine, ecstasy, methadone, phencyclidine, tricyclic&#xD;
               antidepressants, or alcohol Breathalyzer test allowed for alcohol).&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Healthy adult males will be enrolled.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>MD</last_name>
      <role>Study Director</role>
      <affiliation>Amgen</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>
    <link>
      <url>http://www.amgentrials.com</url>
      <description>AmgenTrials clinical trials website</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Vasculitis</keyword>
    <keyword>Complement</keyword>
    <keyword>C5aR</keyword>
    <keyword>Vascular diseases</keyword>
    <keyword>Cardiovascular diseases</keyword>
    <keyword>Systemic lupus erythematosus</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vasculitis</mesh_term>
      <mesh_term>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
      <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.</ipd_access_criteria>
      <ipd_url>http://www.amgen.com/datasharing</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004960
  org study id: CL004_168
  nct id: NCT06004960
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The primary objective of this study is to perform mass balance following a single oral dose
        of [14C]CCX168 in healthy adult male participants.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Urine
  time frame: Up to Day 15
  measure: Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Feces
  time frame: Up to Day 15
  measure: Maximum Observed Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood
  time frame: Up to Day 10
  measure: Time of Occurrence of Maximum Observed Concentration (Tmax) of Total Radioactivity in Plasma and Whole Blood
  time frame: Up to Day 10
  measure: Elimination Rate Constant (λz) of Total Radioactivity in Plasma and Whole Blood
  time frame: Up to Day 10
  measure: Apparent Terminal Half-life (t½z) of Total Radioactivity in Plasma and Whole Blood
  time frame: Up to Day 10
  measure: Apparent Total Clearance (CL/F) of Total Radioactivity in Plasma and Whole Blood
  time frame: Up to Day 10
  measure: Apparent Volume of Distribution (Vz/F) of Total Radioactivity in Plasma and Whole Blood
  time frame: Up to Day 10
  measure: Area Under the Concentration-Time Curve from Time 0 to Time t (AUC0-t) of Total Radioactivity in Plasma and Whole Blood
  time frame: Up to Day 10
  measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of Total Radioactivity in Plasma and Whole Blood
  time frame: Up to Day 10
  measure: Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of Total Radioactivity in Plasma and Whole Blood
  time frame: Up to 24 hours
  measure: Cmax of CCX168 and Metabolites in Plasma
  time frame: Up to Day 10
  measure: Tmax of CCX168 and Metabolites in Plasma
  time frame: Up to Day 10
  measure: λz of CCX168 and Metabolites in Plasma
  time frame: Up to Day 10
  measure: t½z of CCX168 and Metabolites in Plasma
  time frame: Up to Day 10
  measure: CL/F of CCX168 and Metabolites in Plasma
  time frame: Up to Day 10
  measure: Vz/F of CCX168 and Metabolites in Plasma
  time frame: Up to Day 10
  measure: AUC0-t of CCX168 and Metabolites in Plasma
  time frame: Up to Day 10
  measure: AUCinf of CCX168 and Metabolites in Plasma
  time frame: Up to Day 10
  measure: AUC0-24 of CCX168 and Metabolites in Plasma
  time frame: Up to 24 hours
  measure: Percentage of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus
  time frame: Up to Day 15
  measure: Percentage of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus
  time frame: Up to Day 15
  measure: Amount of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus (Auinf + Afinf + Avinf)
  time frame: Up to Day 15
  measure: Amount of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus (Amxuinf + Amxfinf + Amxvinf)
  time frame: Up to Day 15
  measure: Renal Clearance (CLR) of [14C]CCX168
  time frame: Up to Day 15
  measure: Renal Clearance of [14C]-Metabolite (CLRmx)
  time frame: Up to Day 15
  measure: Number of Participants Experiencing Adverse Events (AEs)
  time frame: Up to Day 29
  measure: Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
  time frame: Up to Day 29
  measure: Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
  time frame: Up to Day 29
  arm group label: [14C]CCX168
  arm group type: Experimental
  description: Participants will receive a single oral dose of [14C]CCX168 100 mg containing 400 μCi of [14C] on Day 1.
  intervention type: Drug
  intervention name: [14C]CCX168
  description: Administered orally.
  arm group label: [14C]CCX168
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Healthy adult males will be enrolled.
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: MD
  role: Study Director
  affiliation: Amgen
  facility: 
  country: United States
  url: http://www.amgentrials.com
  description: AmgenTrials clinical trials website
  responsible party type: Sponsor
  mesh term: Vasculitis
  mesh term: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
  sharing ipd: Yes
  ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
  ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
  ipd url: http://www.amgen.com/datasharing