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/NCT05984251</url>
    </required_header>
    <id_info>
      <org_study_id>CL001_168</org_study_id>
      <nct_id>NCT05984251</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants</brief_title>
    <official_title>A Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Male and Female Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Amgen</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Amgen</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>
        The primary objective of this study will be to evaluate the safety and tolerability of single&#xD;
        and multiple oral doses of CCX168, over a range of dose levels, in healthy male and female&#xD;
        participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 21, 2009</start_date>
    <completion_date type="Actual">April 11, 2011</completion_date>
    <primary_completion_date type="Actual">September 19, 2010</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>Basic Science</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants Experiencing Adverse Events (AEs)</measure>
      <time_frame>Up to 43 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters</measure>
      <time_frame>Up to 29 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters</measure>
      <time_frame>Up to 29 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters</measure>
      <time_frame>Up to 29 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum Plasma Concentration (Cmax) of CCX168</measure>
      <time_frame>Period 1: Up to Day 8; Period 2: Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of Cmax of CCX168</measure>
      <time_frame>Period 1: Up to Day 8; Period 2: Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal Phase Rate Constant of CCX168</measure>
      <time_frame>Period 1: Up to Day 8; Period 2: Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent Terminal Half-life of CCX168</measure>
      <time_frame>Period 1: Up to Day 8; Period 2: Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent Oral Clearance of CCX168</measure>
      <time_frame>Period 1: Up to Day 8; Period 2: Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent Volume of Distribution of CCX168</measure>
      <time_frame>Period 1: Up to Day 8; Period 2: Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t</measure>
      <time_frame>Period 1: Up to Day 8; Period 2: Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC of CCX168 From Time 0 to Infinity</measure>
      <time_frame>Period 1: Up to Day 8; Period 2: Up to Day 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC of CCX168 From Time 0 to 24 Hours</measure>
      <time_frame>Periods 1 and 2: Up to Hour 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC of CCX168 From Time 0 to 12 Hours</measure>
      <time_frame>Periods 1 and 2: Up to Hour 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC of CCX168 From Time 12 to 24 Hours</measure>
      <time_frame>Periods 1 and 2: Hour 12 to Hour 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Period 2: AUC of CCX168 From Time 0 to the end of the Dosing Interval</measure>
      <time_frame>Cohorts 1-3: Up to Hour 24; Cohorts 4-5: Up to Hour 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Period 2: Accumulation Ratio of CCX168</measure>
      <time_frame>Up to Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Inhibition of complement 5a receptor (C5aR)-dependent Upregulation of CD11b in Peripheral Blood Neutrophils</measure>
      <time_frame>Period 1: Up to Hour 24; Period 2: Up to 12 hours after the first dose on Day 7</time_frame>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Actual">48</enrollment>
    <condition>Vasculitis</condition>
    <condition>Systemic Lupus Erythematosus (SLE)</condition>
    <arm_group>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>During Period 1, participants will receive a single dose of CCX168 1 mg or placebo. During the second study period, participants will receive the same dose as during the first period but once daily (QD) for a period of 7 days continuously.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>During Period 1, participants will receive a single dose of CCX168 3 mg or placebo. During the second study period, participants will receive the same dose as during the first period but QD for a period of 7 days continuously.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>During Period 1, participants will receive a single dose of CCX168 10 mg or placebo. During the second study period, participants will receive the same dose as during the first period but QD for a period of 7 days continuously.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 4</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>During Period 1, participants will receive a single dose of CCX168 30 mg or placebo. During the second study period, participants will receive the same dose as during the first period or placebo twice daily (BID) for a period of 7 days continuously.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 5</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>During Period 1, participants will receive a single dose of CCX168 100 mg or placebo. During the second study period, participants will receive the same dose as during the first period or placebo BID for a period of 7 days continuously.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CCX168</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_label>Cohort 3</arm_group_label>
      <arm_group_label>Cohort 4</arm_group_label>
      <arm_group_label>Cohort 5</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_label>Cohort 3</arm_group_label>
      <arm_group_label>Cohort 4</arm_group_label>
      <arm_group_label>Cohort 5</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female participants, aged 19-45 years inclusive, who are in generally good&#xD;
               health, whose body mass index is 19 to 29 kg/m^2;&#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 ECG), and clinical laboratory assessments. Participants with&#xD;
               clinical laboratory values that are outside of normal limits and/or with other&#xD;
               abnormal clinical findings that are judged by the Investigator not to be of clinical&#xD;
               significance may be entered into the study, and&#xD;
  &#xD;
            -  Female participants of childbearing potential, and male participants with partners of&#xD;
               childbearing potential, may participate if adequate contraception is used during, and&#xD;
               for at least the four weeks after, any administration of study medication.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women who are pregnant, breastfeeding, or have a positive serum pregnancy test at&#xD;
               Screening and/or on Study Day -1;&#xD;
  &#xD;
            -  Expected requirement for use of any medication (with the exception of continuing use&#xD;
               by female participants of hormonal contraceptives in accordance with a regimen that&#xD;
               has been stable for at least the three months prior to Screening) during the study&#xD;
               period;&#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;
            -  Consumed alcoholic beverages, or any food or drink containing grapefruit or grapefruit&#xD;
               juice within 24 hours of screening;&#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 randomization;&#xD;
  &#xD;
            -  Participant's hemoglobin less than 12 g/dL (or less than 7.45 mmol/L);&#xD;
  &#xD;
            -  Participated in any clinical study of an investigational product within 30 days prior&#xD;
               to randomization;&#xD;
  &#xD;
            -  Participant has any evidence of hepatic disease; aspartate aminotransferase, alanine&#xD;
               aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, or bilirubin &gt;&#xD;
               1.5 x the upper limit of normal;&#xD;
  &#xD;
            -  Participant has any evidence of renal impairment; serum creatinine &gt; 1.5 x upper limit&#xD;
               of normal, and&#xD;
  &#xD;
            -  Participant's urine tested positive at Screening and/or on Study Day -1 for any of the&#xD;
               following: opioids, amphetamines, cannabinoids, benzodiazepines, barbiturates,&#xD;
               cocaine, cotinine, or alcohol (Breathalyzer test allowed for alcohol).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 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>Covance Clinical Research Unit (CRU) AG</name>
        <address>
          <city>Allschwil</city>
          <zip>CH-4123</zip>
          <country>Switzerland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <link>
      <url>http://www.amgentrials.com</url>
      <description>AmgenTrials clinical trials website</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Complement</keyword>
    <keyword>C5aR</keyword>
    <keyword>Vascular diseases</keyword>
    <keyword>Cardiovascular diseases</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vasculitis</mesh_term>
      <mesh_term>Lupus Erythematosus, Systemic</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/NCT05984251
  org study id: CL001_168
  nct id: NCT05984251
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The primary objective of this study will be to evaluate the safety and tolerability of single
        and multiple oral doses of CCX168, over a range of dose levels, in healthy male and female
        participants.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Basic Science
  masking: Double (Participant, Investigator)
  measure: Number of Participants Experiencing Adverse Events (AEs)
  time frame: Up to 43 days
  measure: Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
  time frame: Up to 29 days
  measure: Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
  time frame: Up to 29 days
  measure: Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
  time frame: Up to 29 days
  measure: Maximum Plasma Concentration (Cmax) of CCX168
  time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
  measure: Time of Cmax of CCX168
  time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
  measure: Terminal Phase Rate Constant of CCX168
  time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
  measure: Apparent Terminal Half-life of CCX168
  time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
  measure: Apparent Oral Clearance of CCX168
  time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
  measure: Apparent Volume of Distribution of CCX168
  time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
  measure: Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t
  time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
  measure: AUC of CCX168 From Time 0 to Infinity
  time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
  measure: AUC of CCX168 From Time 0 to 24 Hours
  time frame: Periods 1 and 2: Up to Hour 24
  measure: AUC of CCX168 From Time 0 to 12 Hours
  time frame: Periods 1 and 2: Up to Hour 12
  measure: AUC of CCX168 From Time 12 to 24 Hours
  time frame: Periods 1 and 2: Hour 12 to Hour 24
  measure: Period 2: AUC of CCX168 From Time 0 to the end of the Dosing Interval
  time frame: Cohorts 1-3: Up to Hour 24; Cohorts 4-5: Up to Hour 12
  measure: Period 2: Accumulation Ratio of CCX168
  time frame: Up to Day 7
  measure: Percent Inhibition of complement 5a receptor (C5aR)-dependent Upregulation of CD11b in Peripheral Blood Neutrophils
  time frame: Period 1: Up to Hour 24; Period 2: Up to 12 hours after the first dose on Day 7
  arm group label: Cohort 1
  arm group type: Experimental
  description: During Period 1, participants will receive a single dose of CCX168 1 mg or placebo. During the second study period, participants will receive the same dose as during the first period but once daily (QD) for a period of 7 days continuously.
  arm group label: Cohort 2
  arm group type: Experimental
  description: During Period 1, participants will receive a single dose of CCX168 3 mg or placebo. During the second study period, participants will receive the same dose as during the first period but QD for a period of 7 days continuously.
  arm group label: Cohort 3
  arm group type: Experimental
  description: During Period 1, participants will receive a single dose of CCX168 10 mg or placebo. During the second study period, participants will receive the same dose as during the first period but QD for a period of 7 days continuously.
  arm group label: Cohort 4
  arm group type: Experimental
  description: During Period 1, participants will receive a single dose of CCX168 30 mg or placebo. During the second study period, participants will receive the same dose as during the first period or placebo twice daily (BID) for a period of 7 days continuously.
  arm group label: Cohort 5
  arm group type: Experimental
  description: During Period 1, participants will receive a single dose of CCX168 100 mg or placebo. During the second study period, participants will receive the same dose as during the first period or placebo BID for a period of 7 days continuously.
  intervention type: Drug
  intervention name: CCX168
  description: Administered orally.
  arm group label: Cohort 1
  arm group label: Cohort 2
  arm group label: Cohort 3
  arm group label: Cohort 4
  arm group label: Cohort 5
  intervention type: Drug
  intervention name: Placebo
  description: Administered orally.
  arm group label: Cohort 1
  arm group label: Cohort 2
  arm group label: Cohort 3
  arm group label: Cohort 4
  arm group label: Cohort 5
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: MD
  role: Study Director
  affiliation: Amgen
  facility: 
  country: Switzerland
  url: http://www.amgentrials.com
  description: AmgenTrials clinical trials website
  responsible party type: Sponsor
  mesh term: Vasculitis
  mesh term: Lupus Erythematosus, Systemic
  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