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/NCT05988008</url>
    </required_header>
    <id_info>
      <org_study_id>CCX1101</org_study_id>
      <nct_id>NCT05988008</nct_id>
    </id_info>
    <brief_title>A Study of CCX168 in Japanese and Caucasian Healthy Adult Males</brief_title>
    <official_title>A Phase I Clinical Study of CCX168 in Japanese and Caucasian Healthy Adult Males</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 objectives of the study will be to investigate the safety and pharmacokinetics of a&#xD;
        single oral administration and a twice-daily multiple oral administration of CCX168 in&#xD;
        Japanese healthy adult males; and to compare the pharmacokinetics of a single oral&#xD;
        administration and a twice-daily multiple oral administration of CCX168 between Japanese and&#xD;
        Caucasian healthy adult males.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 23, 2017</start_date>
    <completion_date type="Actual">September 20, 2018</completion_date>
    <primary_completion_date type="Actual">January 26, 2018</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>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants Experiencing Adverse Events</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants Experiencing Adverse Drug Reactions</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants Experiencing Clinically Significant Changes in Clinical Laboratory Parameters</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum Plasma Concentration (Cmax) of CCX168</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cmax of CCX168-M1 (Metabolite)</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Time of Cmax (tmax) of CCX168</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Tmax of CCX168-M1</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Plasma Concentration Time Curve (AUC) from Time 0 to Infinity (AUC0-inf) of CCX168</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC0-inf of CCX168-M1</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC from Time 0 to Time of Last Measurable Plasma Concentration (AUC0-tz) of CCX168</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC0-tz of CCX168-M1</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC During a Dosing Interval of CCX168</measure>
      <time_frame>Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC During a Dosing Interval of CCX168-M1</measure>
      <time_frame>Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Terminal Elimination Half-life of CCX168</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Terminal Elimination Half-life of CCX168-M1</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Apparent Oral Clearance of CCX168</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Apparent Volume of Distribution During the Terminal Phase of CCX168</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean Residence Time to Infinity of CCX168</measure>
      <time_frame>Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Accumulation Ratio of CCX168</measure>
      <time_frame>Cohorts B and D only: Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Accumulation Ratio of CCX168-M1</measure>
      <time_frame>Cohorts B and D only: Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Trough Plasma Concentration at the End of Dosing Interval of CCX168</measure>
      <time_frame>Cohorts B and D only: Up to 14 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Trough Plasma Concentration at the End of Dosing Interval of CCX168-M1</measure>
      <time_frame>Cohorts B and D only: Up to 14 days</time_frame>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">80</enrollment>
    <condition>Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis</condition>
    <arm_group>
      <arm_group_label>Cohort A: Single Oral Dosing of CCX168 in Japanese Adult Males</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy Japanese adult males will receive 1 of 3 single oral doses of CCX168 (10 mg, 30 mg or 100 mg) or placebo. Each dose level will be administered under fasted conditions. Single doses of CCX168 30 mg will be administered under fasted and fed conditions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort B: Multiple Oral Dosing of CCX168 in Japanese Adult Males</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy Japanese adult males will receive 1 of 2 oral doses of CCX168 (30 mg or 50 mg) or placebo twice-daily for 7 days under fed conditions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort C: Single Oral Dosing of CCX168 in Caucasian Adult Males</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy Caucasian adult males will receive 1 of 2 single oral doses of CCX168 (10 mg or 30 mg) or placebo under fasted conditions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort D: Multiple Oral Dosing of CCX168 in Caucasian Adult Males</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy Caucasian adult males will receive an oral dose of CCX168 30 mg or placebo twice-daily for 7 days under fed conditions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CCX168</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>Cohort A: Single Oral Dosing of CCX168 in Japanese Adult Males</arm_group_label>
      <arm_group_label>Cohort B: Multiple Oral Dosing of CCX168 in Japanese Adult Males</arm_group_label>
      <arm_group_label>Cohort C: Single Oral Dosing of CCX168 in Caucasian Adult Males</arm_group_label>
      <arm_group_label>Cohort D: Multiple Oral Dosing of CCX168 in Caucasian Adult Males</arm_group_label>
      <other_name>Avacopan</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>Cohort A: Single Oral Dosing of CCX168 in Japanese Adult Males</arm_group_label>
      <arm_group_label>Cohort B: Multiple Oral Dosing of CCX168 in Japanese Adult Males</arm_group_label>
      <arm_group_label>Cohort C: Single Oral Dosing of CCX168 in Caucasian Adult Males</arm_group_label>
      <arm_group_label>Cohort D: Multiple Oral Dosing of CCX168 in Caucasian Adult Males</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Japanese and Caucasian healthy males aged 20 to 45 years inclusive (at the time of&#xD;
               obtaining informed consent);&#xD;
  &#xD;
            -  Body Mass Index (body weight [kg]/squared height [m^2]): 18.5 kg/m^2 or more and less&#xD;
               than 25 kg/m^2 for Japanese males or between 18.5 and 29 kg/m^2 for Caucasian males&#xD;
               (at the time of screening visit);&#xD;
  &#xD;
            -  Body weight: 50 kg or more and less than 90 kg (at the time of screening visit).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants with any abnormal findings (e.g., clinical laboratory test values outside&#xD;
               the reference range) during the physical examination and other tests (vital signs,&#xD;
               12-lead ECG and clinical laboratory tests) that are judged by the principal&#xD;
               investigator or subinvestigator to be clinically significant;&#xD;
  &#xD;
            -  Participants who test positive for immunological tests (hepatitis B surface antigen,&#xD;
               hepatitis C virus antibody, serological reaction of syphilis, and human&#xD;
               immunodeficiency virus antigen and antibody);&#xD;
  &#xD;
            -  Participants with a history of drug allergy;&#xD;
  &#xD;
            -  Participants who are a habitual alcohol drinker with an average pure alcohol intake of&#xD;
               over 40 g/day;&#xD;
  &#xD;
            -  Participants who test positive for abuse of phencyclidines, benzodiazepines, cocaine,&#xD;
               stimulants, cannabis, morphine, barbiturates, and tricyclic antidepressants during&#xD;
               urine drug testing;&#xD;
  &#xD;
            -  Male participant who do not agree to use adequate contraception for a period from a&#xD;
               start of the investigational product administration to 12 weeks after the final&#xD;
               administration of the investigational product;&#xD;
  &#xD;
            -  Participants with a QTcF intervals of 450 msec or greater in the 12-lead ECG at the&#xD;
               time of the screening visit and/or Day -1;&#xD;
  &#xD;
            -  Participants who consumed tobacco or a nicotine patch/gum within 12 weeks prior to the&#xD;
               investigational product administration;&#xD;
  &#xD;
            -  Participants who received other prescription medications or over-the-counter&#xD;
               medications (including vitamins and energy drinks) within 2 weeks prior to the&#xD;
               investigational product administration (excluding topical formulation that is not&#xD;
               expected systemic action);&#xD;
  &#xD;
            -  Participants who received any supplements (Saint John's wort [Hypericum perforatum]&#xD;
               etc.) that have been reported to affect the pharmacokinetics of concomitant use of&#xD;
               drugs within 2 weeks prior to the investigational product administration;&#xD;
  &#xD;
            -  Participants who received a grapefruit and an orange that contain the component&#xD;
               inhibiting CYP3A4 or the food and drink containing these fruits within 1 week prior to&#xD;
               the investigational product administration;&#xD;
  &#xD;
            -  Participants who received other investigational products within 16 weeks prior to the&#xD;
               investigational product administration;&#xD;
  &#xD;
            -  Participants who donated more than 200 mL of blood (donation of whole blood, plasma&#xD;
               components or platelets, etc.) within 4 weeks or more than 400 mL within 16 weeks&#xD;
               prior to the investigational product administration;&#xD;
  &#xD;
            -  Participants who performed excessive exercise with symptoms of fatigue or muscle pain&#xD;
               within 1 week prior to the investigational product administration;&#xD;
  &#xD;
            -  Participants who are judged by the principal investigator or subinvestigator as&#xD;
               inappropriate for inclusion in this study.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>45 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>Sumida Hospital, SOUSEIKAI Global Clinical Research Center</name>
        <address>
          <city>Sumida City</city>
          <state>Tokyo</state>
          <zip>130-0004</zip>
          <country>Japan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Japan</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 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Human C5a receptor (C5aR)</keyword>
    <keyword>Vasculitis</keyword>
    <keyword>Complement</keyword>
    <keyword>Vascular disease</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/NCT05988008
  org study id: CCX1101
  nct id: NCT05988008
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The objectives of the study will be to investigate the safety and pharmacokinetics of a
        single oral administration and a twice-daily multiple oral administration of CCX168 in
        Japanese healthy adult males; and to compare the pharmacokinetics of a single oral
        administration and a twice-daily multiple oral administration of CCX168 between Japanese and
        Caucasian healthy adult males.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: Single (Participant)
  measure: Number of Participants Experiencing Adverse Events
  time frame: Up to 14 days
  measure: Number of Participants Experiencing Adverse Drug Reactions
  time frame: Up to 14 days
  measure: Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
  time frame: Up to 14 days
  measure: Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
  time frame: Up to 14 days
  measure: Number of Participants Experiencing Clinically Significant Changes in Clinical Laboratory Parameters
  time frame: Up to 14 days
  measure: Maximum Plasma Concentration (Cmax) of CCX168
  time frame: Up to 14 days
  measure: Cmax of CCX168-M1 (Metabolite)
  time frame: Up to 14 days
  measure: Time of Cmax (tmax) of CCX168
  time frame: Up to 14 days
  measure: Tmax of CCX168-M1
  time frame: Up to 14 days
  measure: Area Under the Plasma Concentration Time Curve (AUC) from Time 0 to Infinity (AUC0-inf) of CCX168
  time frame: Up to 14 days
  measure: AUC0-inf of CCX168-M1
  time frame: Up to 14 days
  measure: AUC from Time 0 to Time of Last Measurable Plasma Concentration (AUC0-tz) of CCX168
  time frame: Up to 14 days
  measure: AUC0-tz of CCX168-M1
  time frame: Up to 14 days
  measure: AUC During a Dosing Interval of CCX168
  time frame: Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7
  measure: AUC During a Dosing Interval of CCX168-M1
  time frame: Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7
  measure: Terminal Elimination Half-life of CCX168
  time frame: Up to 14 days
  measure: Terminal Elimination Half-life of CCX168-M1
  time frame: Up to 14 days
  measure: Apparent Oral Clearance of CCX168
  time frame: Up to 14 days
  measure: Apparent Volume of Distribution During the Terminal Phase of CCX168
  time frame: Up to 14 days
  measure: Mean Residence Time to Infinity of CCX168
  time frame: Up to 14 days
  measure: Accumulation Ratio of CCX168
  time frame: Cohorts B and D only: Up to 14 days
  measure: Accumulation Ratio of CCX168-M1
  time frame: Cohorts B and D only: Up to 14 days
  measure: Trough Plasma Concentration at the End of Dosing Interval of CCX168
  time frame: Cohorts B and D only: Up to 14 days
  measure: Trough Plasma Concentration at the End of Dosing Interval of CCX168-M1
  time frame: Cohorts B and D only: Up to 14 days
  arm group label: Cohort A: Single Oral Dosing of CCX168 in Japanese Adult Males
  arm group type: Experimental
  description: Healthy Japanese adult males will receive 1 of 3 single oral doses of CCX168 (10 mg, 30 mg or 100 mg) or placebo. Each dose level will be administered under fasted conditions. Single doses of CCX168 30 mg will be administered under fasted and fed conditions.
  arm group label: Cohort B: Multiple Oral Dosing of CCX168 in Japanese Adult Males
  arm group type: Experimental
  description: Healthy Japanese adult males will receive 1 of 2 oral doses of CCX168 (30 mg or 50 mg) or placebo twice-daily for 7 days under fed conditions.
  arm group label: Cohort C: Single Oral Dosing of CCX168 in Caucasian Adult Males
  arm group type: Experimental
  description: Healthy Caucasian adult males will receive 1 of 2 single oral doses of CCX168 (10 mg or 30 mg) or placebo under fasted conditions.
  arm group label: Cohort D: Multiple Oral Dosing of CCX168 in Caucasian Adult Males
  arm group type: Experimental
  description: Healthy Caucasian adult males will receive an oral dose of CCX168 30 mg or placebo twice-daily for 7 days under fed conditions.
  intervention type: Drug
  intervention name: CCX168
  description: Administered orally.
  arm group label: Cohort A: Single Oral Dosing of CCX168 in Japanese Adult Males
  arm group label: Cohort B: Multiple Oral Dosing of CCX168 in Japanese Adult Males
  arm group label: Cohort C: Single Oral Dosing of CCX168 in Caucasian Adult Males
  arm group label: Cohort D: Multiple Oral Dosing of CCX168 in Caucasian Adult Males
  other name: Avacopan
  intervention type: Drug
  intervention name: Placebo
  description: Administered orally.
  arm group label: Cohort A: Single Oral Dosing of CCX168 in Japanese Adult Males
  arm group label: Cohort B: Multiple Oral Dosing of CCX168 in Japanese Adult Males
  arm group label: Cohort C: Single Oral Dosing of CCX168 in Caucasian Adult Males
  arm group label: Cohort D: Multiple Oral Dosing of CCX168 in Caucasian Adult Males
  criteria: 
  gender: Male
  minimum age: 20 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: MD
  role: Study Director
  affiliation: Amgen
  facility: 
  country: Japan
  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