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/NCT06004947</url>
    </required_header>
    <id_info>
      <org_study_id>CL008_168</org_study_id>
      <nct_id>NCT06004947</nct_id>
    </id_info>
    <brief_title>A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications</brief_title>
    <official_title>An Open-Label, Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications</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 will be to evaluate the drug-drug interaction potential&#xD;
        of CCX168 with concomitant medications, as either a perpetrator or a victim, following oral&#xD;
        administration of CCX168 to healthy participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 14, 2016</start_date>
    <completion_date type="Actual">June 10, 2016</completion_date>
    <primary_completion_date type="Actual">March 15, 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>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cohort A: Maximum Plasma Concentration (Cmax) of Midazolam</measure>
      <time_frame>Up to Day 13</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort A: Cmax of Celecoxib</measure>
      <time_frame>Up to Day 13</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort A: Time of Cmax (Tmax) of Midazolam</measure>
      <time_frame>Up to Day 13</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort A: Tmax of Celecoxib</measure>
      <time_frame>Up to Day 13</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort A: Area under the plasma concentration-time curve (AUC) from Time 0 to infinity of Midazolam</measure>
      <time_frame>Up to Day 13</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort A: AUC from Time 0 to infinity of Celecoxib</measure>
      <time_frame>Up to Day 13</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort A: Apparent Terminal Half Life of Midazolam</measure>
      <time_frame>Up to Day 13</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort A: Apparent Terminal Half Life of Celecoxib</measure>
      <time_frame>Up to Day 13</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort A: Cmax of CCX168</measure>
      <time_frame>Day 15 up to Day 19</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort A: Tmax of CCX168</measure>
      <time_frame>Day 15 up to Day 19</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort A: AUC Over the Dosing Interval of CCX168</measure>
      <time_frame>Day 15 up to Day 19</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort B: Cmax of CCX168</measure>
      <time_frame>Up to Day 14</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort B: Tmax of CCX168</measure>
      <time_frame>Up to Day 14</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort B: AUC from Time 0 to infinity of CCX168</measure>
      <time_frame>Up to Day 14</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort B: Apparent Terminal Half Life of CCX168</measure>
      <time_frame>Up to Day 14</time_frame>
    </primary_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 19</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters</measure>
      <time_frame>Up to Day 19</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">32</enrollment>
    <condition>Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis</condition>
    <arm_group>
      <arm_group_label>Cohort A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A single dose of 2 mg midazolam (a Cytochrome P450 [CYP]3A4 probe drug) and a single dose of 200 mg celecoxib (a CYP2C9 probe drug) will be given orally concurrently on Day 1 and Day 13. On Day 3 through Day 18, CCX168 will be given orally at 30 mg twice daily (b.i.d.), and a single dose of 30 mg CCX168 will be given in the morning on Day 19. On Day 16 through Day 19, a once daily (q.d.) dose of 200 mg itraconazole (a CYP3A4 inhibitor) will be given orally.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A single dose of 30 mg CCX168 will be given on Day 1 and Day 14, while rifampicin (a CYP3A4 inducer) will be given at 600 mg once daily from Day 4 through Day 17.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CCX168</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>Cohort A</arm_group_label>
      <arm_group_label>Cohort B</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Midazolam</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>Cohort A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Celecoxib</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>Cohort A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Itraconazole</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>Cohort A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rifampicin</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>Cohort B</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 as judged by the Investigator, whose body mass index is 19.0 to 32.0 kg/m^2&#xD;
               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;
            -  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;
            -  Pregnant or breastfeeding;&#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; herbal supplements must be stopped 7 days prior to check-in;&#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; strenuous exercise&#xD;
               must be stopped 4 days prior to check-in;&#xD;
  &#xD;
            -  History within the three months prior to check-in of use of tobacco and/or nicotine&#xD;
               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;
            -  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;
               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 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 check-in for any of the&#xD;
               following: opioids, amphetamines and methamphetamines, cannabinoids, benzodiazepines,&#xD;
               barbiturates, cocaine, cotinine, methylenedioxymethamphetamine (MDMA or &quot;ecstasy&quot;),&#xD;
               methadone, phencyclidine, tri-cyclic antidepressants, or alcohol (Breathalyzer test&#xD;
               allowed for alcohol).&#xD;
  &#xD;
            -  Participant is known as a CYP2C9 poor metabolizer.&#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>August 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>Renal diseases</keyword>
    <keyword>Atypical hemolytic uremic syndrome</keyword>
    <keyword>Immunoglobulin A nephropathy</keyword>
    <keyword>Complement 5a receptor (C5aR)</keyword>
    <keyword>Complement</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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Itraconazole</mesh_term>
      <mesh_term>Rifampin</mesh_term>
      <mesh_term>Celecoxib</mesh_term>
      <mesh_term>Midazolam</mesh_term>
    </intervention_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/NCT06004947
  org study id: CL008_168
  nct id: NCT06004947
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The primary objective of this study will be to evaluate the drug-drug interaction potential
        of CCX168 with concomitant medications, as either a perpetrator or a victim, following oral
        administration of CCX168 to healthy participants.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Cohort A: Maximum Plasma Concentration (Cmax) of Midazolam
  time frame: Up to Day 13
  measure: Cohort A: Cmax of Celecoxib
  time frame: Up to Day 13
  measure: Cohort A: Time of Cmax (Tmax) of Midazolam
  time frame: Up to Day 13
  measure: Cohort A: Tmax of Celecoxib
  time frame: Up to Day 13
  measure: Cohort A: Area under the plasma concentration-time curve (AUC) from Time 0 to infinity of Midazolam
  time frame: Up to Day 13
  measure: Cohort A: AUC from Time 0 to infinity of Celecoxib
  time frame: Up to Day 13
  measure: Cohort A: Apparent Terminal Half Life of Midazolam
  time frame: Up to Day 13
  measure: Cohort A: Apparent Terminal Half Life of Celecoxib
  time frame: Up to Day 13
  measure: Cohort A: Cmax of CCX168
  time frame: Day 15 up to Day 19
  measure: Cohort A: Tmax of CCX168
  time frame: Day 15 up to Day 19
  measure: Cohort A: AUC Over the Dosing Interval of CCX168
  time frame: Day 15 up to Day 19
  measure: Cohort B: Cmax of CCX168
  time frame: Up to Day 14
  measure: Cohort B: Tmax of CCX168
  time frame: Up to Day 14
  measure: Cohort B: AUC from Time 0 to infinity of CCX168
  time frame: Up to Day 14
  measure: Cohort B: Apparent Terminal Half Life of CCX168
  time frame: Up to Day 14
  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 19
  measure: Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
  time frame: Up to Day 19
  arm group label: Cohort A
  arm group type: Experimental
  description: A single dose of 2 mg midazolam (a Cytochrome P450 [CYP]3A4 probe drug) and a single dose of 200 mg celecoxib (a CYP2C9 probe drug) will be given orally concurrently on Day 1 and Day 13. On Day 3 through Day 18, CCX168 will be given orally at 30 mg twice daily (b.i.d.), and a single dose of 30 mg CCX168 will be given in the morning on Day 19. On Day 16 through Day 19, a once daily (q.d.) dose of 200 mg itraconazole (a CYP3A4 inhibitor) will be given orally.
  arm group label: Cohort B
  arm group type: Experimental
  description: A single dose of 30 mg CCX168 will be given on Day 1 and Day 14, while rifampicin (a CYP3A4 inducer) will be given at 600 mg once daily from Day 4 through Day 17.
  intervention type: Drug
  intervention name: CCX168
  description: Administered orally.
  arm group label: Cohort A
  arm group label: Cohort B
  intervention type: Drug
  intervention name: Midazolam
  description: Administered orally.
  arm group label: Cohort A
  intervention type: Drug
  intervention name: Celecoxib
  description: Administered orally.
  arm group label: Cohort A
  intervention type: Drug
  intervention name: Itraconazole
  description: Administered orally.
  arm group label: Cohort A
  intervention type: Drug
  intervention name: Rifampicin
  description: Administered orally.
  arm group label: Cohort B
  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
  mesh term: Itraconazole
  mesh term: Rifampin
  mesh term: Celecoxib
  mesh term: Midazolam
  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