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/NCT05988021</url>
    </required_header>
    <id_info>
      <org_study_id>CL007_168</org_study_id>
      <nct_id>NCT05988021</nct_id>
    </id_info>
    <brief_title>A Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168</brief_title>
    <official_title>An Open-Label, Phase 1 Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168</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 clinical trial is to evaluate the effect of a high-fat,&#xD;
        high-calorie meal on the pharmacokinetic (PK) profile of CCX168, following oral&#xD;
        administration of a single dose of 30 mg CCX168 to healthy volunteers.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 3, 2015</start_date>
    <completion_date type="Actual">May 25, 2016</completion_date>
    <primary_completion_date type="Actual">February 9, 2016</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum Plasma Concentration (Cmax) of CCX168</measure>
      <time_frame>Up to 35 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Time of Cmax (Tmax) of CCX168</measure>
      <time_frame>Up to 35 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t (AUC0-t)</measure>
      <time_frame>Up to 35 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC of CCX168 From Time 0 to Infinity (AUC0-inf)</measure>
      <time_frame>Up to 35 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters</measure>
      <time_frame>Up to 35 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Adverse Events (AEs)</measure>
      <time_frame>Up to 35 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters</measure>
      <time_frame>Up to 35 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters</measure>
      <time_frame>Up to 35 days</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">16</enrollment>
    <condition>Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis</condition>
    <arm_group>
      <arm_group_label>Cohort 1: Sequence ABCD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants assigned to sequence ABCD will receive the following treatments:&#xD;
  Period 1: Single dose of 30 mg CCX168 after a high-fat, high-calorie meal (Treatment A).&#xD;
  Period 2: After a washout period of ≥ 10 days, single dose of 30 mg CCX168 in the fasted state (Treatment B).&#xD;
  Period 3: After a washout period of ≥ 10 days, single dose of 3 mg CCX168 in the fasted state (Treatment C).&#xD;
  Period 4: 24 hours after the 3 mg CCX168 dose in Period 3, single dose of 100 mg CCX168 on Day 1, and then 100 mg CCX168 twice daily from Day 2 through Day 6. On Day 7, only a morning dose of 100 mg CCX168 (Treatment D).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2: Sequence BACD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants assigned to sequence BACD will receive the following treatments:&#xD;
  Period 1: Single dose of 30 mg CCX168 in the fasted state (Treatment B).&#xD;
  Period 2: After a washout period of ≥ 10 days, single dose of 30 mg CCX168 after a high-fat, high-calorie meal (Treatment A).&#xD;
  Period 3: After a washout period of ≥ 10 days, single dose of 3 mg CCX168 in the fasted state (Treatment C).&#xD;
  Period 4: 24 hours after the 3 mg CCX168 dose in Period 3, single dose of 100 mg CCX168 on Day 1, and then 100 mg CCX168 twice daily from Day 2 through Day 6. On Day 7, only a morning dose of 100 mg CCX168 (Treatment D).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CCX168</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>Cohort 1: Sequence ABCD</arm_group_label>
      <arm_group_label>Cohort 2: Sequence BACD</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female participants, aged 18-55 years inclusive, who are in generally good&#xD;
               health, whose body mass index is 19.0 to 32.0 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 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;&#xD;
  &#xD;
            -  Female participants of childbearing potential, or male participants with partners of&#xD;
               childbearing potential may participate if adequate contraception is used during, and&#xD;
               for at least 90 days after, any administration of study medication.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women who are pregnant, lactating, or have a positive serum pregnancy test at&#xD;
               screening or check-in (Day -2);&#xD;
  &#xD;
            -  Myocardial infarction or active ischemic heart disease within 12 months before&#xD;
               screening;&#xD;
  &#xD;
            -  Significant abnormal ECG: Pacemaker, any conduction abnormality associated with a QRS&#xD;
               ≥120 msec, poorly-defined or abnormal T wave morphology precluding end of T&#xD;
               measurement, abnormal rhythm for age, evidence of previous myocardial infarction (Q&#xD;
               waves, S-T segment changes), sinus pauses &gt; 2.5 seconds, ventricular couplets,&#xD;
               triplets or other arrhythmia, symptomatic or asymptomatic;&#xD;
  &#xD;
            -  Has any of the following abnormalities:&#xD;
  &#xD;
                 1. Heart rate &lt;40 or &gt;100 bpm&#xD;
  &#xD;
                 2. PR interval &lt;110 or ≥220 msec&#xD;
  &#xD;
                 3. QRS duration ≥120 msec&#xD;
  &#xD;
                 4. QTcF interval &lt;350 or &gt;450 msec;&#xD;
  &#xD;
            -  History of additional significant risk factors for torsade de pointes, including heart&#xD;
               failure, hypokalemia, hypocalcemia, hypomagnesemia, family history of long QT&#xD;
               syndrome;&#xD;
  &#xD;
            -  Used a prescription and/or over-the-counter medication, with the exception of&#xD;
               ibuprofen, hormonal contraceptives, and multi-vitamins, within 14 days prior to&#xD;
               check-in;&#xD;
  &#xD;
            -  History within the three months prior to check-in of use of tobacco and/or&#xD;
               nicotine-containing products;&#xD;
  &#xD;
            -  History within one year prior to check-in of illicit drug use;&#xD;
  &#xD;
            -  History of alcohol abuse at any time in the past;&#xD;
  &#xD;
            -  Has a history or presence of any form of cancer within the 5 years prior to check-in,&#xD;
               with the exception of excised basal cell or squamous cell carcinoma of the skin, or&#xD;
               cervical carcinoma in situ or breast carcinoma in situ that has been excised or&#xD;
               resected completely and is without evidence of local recurrence or metastasis;&#xD;
  &#xD;
            -  For at least 14 days prior to check-in and throughout the blood sample collection&#xD;
               period, participants will not be allowed to eat any food or drink any beverage&#xD;
               containing alcohol, grapefruit or grapefruit juice, apple or orange juice, vegetables&#xD;
               from the mustard green family (e.g., kale, broccoli, watercress, collard greens,&#xD;
               kohlrabi, Brussels sprouts, mustard greens) and charbroiled meats;&#xD;
  &#xD;
            -  History or presence of unexplained syncope or family history of sudden death, or any&#xD;
               medical condition or disease which, in the opinion of the Investigator, may place the&#xD;
               participants 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 11.5 g/dL for women or less than 13.0 g/dL for men&#xD;
               at screening or check-in, confirmed by a repeat measurement;&#xD;
  &#xD;
            -  Participated in any clinical study of an investigational product within 30 days prior&#xD;
               to dosing, or within 5 half-lives after dosing;&#xD;
  &#xD;
            -  Participant has any evidence of hepatic disease; aspartate aminotransferase, alanine&#xD;
               aminotransferase, alkaline phosphatase, or bilirubin greater than 1.5 times the upper&#xD;
               limit of normal at screening or check-in;&#xD;
  &#xD;
            -  Participant's white blood cell count is below the lower limit of normal at screening&#xD;
               or check-in, confirmed by a repeat measurement;&#xD;
  &#xD;
            -  Participant has any evidence of renal impairment; serum creatinine greater than 1.5&#xD;
               times the upper limit of normal at screening or check-in;&#xD;
  &#xD;
            -  Participant's urine tested positive at screening and/or on check-in for any of the&#xD;
               following: opioids, amphetamines and methamphetamines, cannabinoids, benzodiazepines,&#xD;
               barbiturates, cocaine, cotinine, ecstasy, methadone, phencyclidine, tri-cyclic&#xD;
               antidepressants, or alcohol (Breathalyzer test allowed for alcohol).&#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>MD</last_name>
      <role>Study Director</role>
      <affiliation>Amgen</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Celerion</name>
        <address>
          <city>Tempe</city>
          <state>Arizona</state>
          <zip>85283</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 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>Vasculitis</keyword>
    <keyword>Complement</keyword>
    <keyword>C5aR</keyword>
    <keyword>Vascular diseases</keyword>
    <keyword>Cardiovascular diseases</keyword>
    <keyword>Systemic vasculitis</keyword>
    <keyword>ANCA</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/NCT05988021
  org study id: CL007_168
  nct id: NCT05988021
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The primary objective of this clinical trial is to evaluate the effect of a high-fat,
        high-calorie meal on the pharmacokinetic (PK) profile of CCX168, following oral
        administration of a single dose of 30 mg CCX168 to healthy volunteers.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Maximum Plasma Concentration (Cmax) of CCX168
  time frame: Up to 35 days
  measure: Time of Cmax (Tmax) of CCX168
  time frame: Up to 35 days
  measure: Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t (AUC0-t)
  time frame: Up to 35 days
  measure: AUC of CCX168 From Time 0 to Infinity (AUC0-inf)
  time frame: Up to 35 days
  measure: Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
  time frame: Up to 35 days
  measure: Number of Participants Experiencing Adverse Events (AEs)
  time frame: Up to 35 days
  measure: Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
  time frame: Up to 35 days
  measure: Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
  time frame: Up to 35 days
  arm group label: Cohort 1: Sequence ABCD
  arm group type: Experimental
  description: Participants assigned to sequence ABCD will receive the following treatments:
  Period 1: Single dose of 30 mg CCX168 after a high-fat, high-calorie meal (Treatment A).
  Period 2: After a washout period of ≥ 10 days, single dose of 30 mg CCX168 in the fasted state (Treatment B).
  Period 3: After a washout period of ≥ 10 days, single dose of 3 mg CCX168 in the fasted state (Treatment C).
  Period 4: 24 hours after the 3 mg CCX168 dose in Period 3, single dose of 100 mg CCX168 on Day 1, and then 100 mg CCX168 twice daily from Day 2 through Day 6. On Day 7, only a morning dose of 100 mg CCX168 (Treatment D).
  arm group label: Cohort 2: Sequence BACD
  arm group type: Experimental
  description: Participants assigned to sequence BACD will receive the following treatments:
  Period 1: Single dose of 30 mg CCX168 in the fasted state (Treatment B).
  Period 2: After a washout period of ≥ 10 days, single dose of 30 mg CCX168 after a high-fat, high-calorie meal (Treatment A).
  Period 3: After a washout period of ≥ 10 days, single dose of 3 mg CCX168 in the fasted state (Treatment C).
  Period 4: 24 hours after the 3 mg CCX168 dose in Period 3, single dose of 100 mg CCX168 on Day 1, and then 100 mg CCX168 twice daily from Day 2 through Day 6. On Day 7, only a morning dose of 100 mg CCX168 (Treatment D).
  intervention type: Drug
  intervention name: CCX168
  description: Administered orally.
  arm group label: Cohort 1: Sequence ABCD
  arm group label: Cohort 2: Sequence BACD
  criteria: 
  gender: All
  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