<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/NCT04407091</url>
  </required_header>
  <id_info>
    <org_study_id>D6580C00007</org_study_id>
    <nct_id>NCT04407091</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolite Profile and Metabolite Identification of [14C]AZD4831</brief_title>
  <official_title>A Phase I, Open-Label, Single-Period Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolite Profile and Metabolite Identification After Oral Administration of [14C]AZD4831 in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quotient Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Sponsor is developing the test medicine, AZD4831, for the potential treatment of&#xD;
      cardiovascular disease (CVD). CVD is a general term to describe a range of conditions that&#xD;
      affect the heart and blood vessels, examples of CVD include angina (chest pain caused by&#xD;
      restricted blood flow to heart muscle) and heart failure (where the heart is unable to pump&#xD;
      blood around the body properly). AZD4831 is an inhibitor of a protein that has a role in the&#xD;
      formation of fatty deposits in arteries (blood vessels that take blood to the body). It is&#xD;
      hoped that by inhibiting this action, AZD4831 will help with the management of CVD.&#xD;
&#xD;
      The study involves radiolabelling (labelling the molecule with radioactive 14C) which is used&#xD;
      to locate the molecule within the body. The study will try to assess how much radioactivity&#xD;
      can be recovered from the urine and faeces (mass balance recovery) after a single oral dose&#xD;
      of [14C]AZD4831. It will also look to identify the breakdown products (metabolites) of the&#xD;
      parent drug. It will additionally determine the rate and route of elimination of&#xD;
      [14C]AZD4831, along with the level of test medicine in the blood. The safety and tolerability&#xD;
      of the test medicine will be assessed. The dose of radiation administered is very low,&#xD;
      therefore the risk associated with this is very small.&#xD;
&#xD;
      The study will consist of a single study period involving up to six healthy male volunteers.&#xD;
      Up to six male volunteers will receive a dose of 10 mg of the radiolabelled test medicine as&#xD;
      an oral solution. Blood, urine and faecal samples will be collected from volunteers whilst&#xD;
      they are resident in the clinical unit for up to 336 hours post-dose (Day 15). A follow-up&#xD;
      visit will take place seven to ten days after discharge for safety assessments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">August 6, 2020</completion_date>
  <primary_completion_date type="Actual">August 6, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The cumulative amount of AZD4831 excreted (CumAe)</measure>
    <time_frame>Urine and faecal samples collected from pre-dose until 336 hours post-dose</time_frame>
    <description>Assessment of the total radioactivity by measuring the cumulative amount of AZD4831 excreted (CumAe)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The cumulative amount of AZD4831 excreted and expressed as a percentage of the administered dose (CumFe)</measure>
    <time_frame>Urine and faecal samples collected from pre-dose until 336 hours post-dose</time_frame>
    <description>Assessment of the total radioactivity by measuring the cumulative amount of AZD4831 excreted and expressed as a percentage of the administered dose (CumFe)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of metabolites in plasma by accelerator mass spectrometry (AMS) analysis</measure>
    <time_frame>Collection of plasma samples from pre-dose until 336 hours post-dose</time_frame>
    <description>Assessment of metabolites and structural identification by AMS analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of metabolites in urine by AMS analysis</measure>
    <time_frame>Collection of urine samples from pre-dose until 336 hours post-dose</time_frame>
    <description>Assessment of metabolites and structural identification by AMS analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of metabolites in faeces by AMS analysis</measure>
    <time_frame>Collection of faecal samples from pre-dose until 336 hours post-dose</time_frame>
    <description>Assessment of metabolites and structural identification by AMS analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The amount of AZD4831 excreted (Ae)</measure>
    <time_frame>Collection of urine and faecal samples from pre-dose to 336 hours post-dose.</time_frame>
    <description>Assessment of the rates and routes of elimination by measuring the amount excreted (Ae)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of AZD4831 excreted and expressed as a percentage of the administered dose (Fe)</measure>
    <time_frame>Collection of urine and faecal samples from pre-dose to 336 hours post-dose</time_frame>
    <description>Assessment of the rates and routes of elimination by measuring the amount excreted and expressing it as a percentage of the administered dose (Fe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The cumulative amount of AZD4831 excreted (CumAe)</measure>
    <time_frame>Collection of urine and faecal samples from pre-dose to 336 hours post-dose</time_frame>
    <description>Assessment of the rates and routes of elimination by measuring the cumulative amount excreted (CumAe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The cumulative amount of AZD4831 excreted and expressed as a percentage of the administered dose (CumFe)</measure>
    <time_frame>Collection of urine and faecal samples from pre-dose to 336 hours post-dose</time_frame>
    <description>Assessment of the rates and routes of elimination by measuring the cumulative amount excreted and expressed as a percentage of the administered dose (CumFe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration (tmax) for AZD4831 and total radioactivity</measure>
    <time_frame>Collection of plasma samples from pre-dose to 336 hours post-dose</time_frame>
    <description>Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the time to maximum concentration (tmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (cmax) for AZD4831 and total radioactivity</measure>
    <time_frame>Collection of plasma samples from pre-dose to 336 hours post-dose</time_frame>
    <description>Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the maximum concentration (cmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration time curve from time zero to the time of the last measureable concentration (AUC0-t) for AZD4831 and total radioactivity</measure>
    <time_frame>Collection of plasma samples from pre-dose to 336 hours post-dose</time_frame>
    <description>Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the concentration time curve from time zero to the last measureable concentration (AUC0-t)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration time curve from time zero to the last quantifiable concentration (AUC0-inf) for AZD4831 and total radioactivity</measure>
    <time_frame>Collection of plasma samples from pre-dose to 336 hours post-dose</time_frame>
    <description>Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the concentration time curve from time zero extrapolated to infinity (AUC0-inf)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration time curve from time of the last measureable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC%extrap)</measure>
    <time_frame>Collection of plasma samples from pre-dose to 336 hours post-dose</time_frame>
    <description>Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the concentration time curve from time of the last measureable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC%extrap)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent terminal elimination half-life (t1/2) for AZD4831 and total radioactivity</measure>
    <time_frame>Collection of plasma samples from pre-dose to 336 hours post-dose</time_frame>
    <description>Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the terminal elimination half-life (t1/2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First order rate constant associated with the terminal (log-linear) portion of the curve for AZD4831 and total radioactivity</measure>
    <time_frame>Collection of plasma samples from pre-dose to 336 hours post-dose</time_frame>
    <description>Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the first order rate constant associated with the terminal (log-linear) portion of the curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total body clearance (CL/F) of AZD4831 and total radioactivity</measure>
    <time_frame>Collection of plasma samples from pre-dose to 336 hours post-dose</time_frame>
    <description>Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring total body clearance (CL/F)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution (Vz/F) of AZD4831 and total radioactivity</measure>
    <time_frame>Collection of plasma samples from pre-dose to 336 hours post-dose</time_frame>
    <description>Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the apparent volume of distribution (Vz/F)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance (CLR) of AZD4831 in urine</measure>
    <time_frame>Collection of urine samples from pre-dose to 36 hours post-dose</time_frame>
    <description>Assessment of pharmacokinetics of AZD4831 by measuring renal clearance (CLR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of whole blood to plasma concentration ratios for total radioactivity</measure>
    <time_frame>Collection of blood samples until 336 hours post-dose</time_frame>
    <description>Assessment of total radioactivity in whole blood and plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events (AE) experienced by subjects</measure>
    <time_frame>AEs recorded from the time of informed consent until discharge from the study (336 hours post-dose)</time_frame>
    <description>Safety and tolerability assessed through the incidence of AEs</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Identification of the chemical structure of major metabolite(s) in plasma</measure>
    <time_frame>Plasma samples collected until 336 hours post-dose</time_frame>
    <description>Identification of chemical structure of major metabolites of AZD4831</description>
  </other_outcome>
  <other_outcome>
    <measure>Identification of the chemical structure of major metabolite(s) in urine</measure>
    <time_frame>Urine samples collected until 336 hours post-dose</time_frame>
    <description>Identification of chemical structure of major metabolites of AZD4831</description>
  </other_outcome>
  <other_outcome>
    <measure>Identification of the chemical structure of major metabolite(s) in faeces</measure>
    <time_frame>Faeces samples collected until 336 hours post-dose</time_frame>
    <description>Identification of chemical structure of major metabolites of AZD4831</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>[14C]AZD4831 Oral Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One 10 mg dose of [14C]AZD4831 Oral Solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>14C]AZD4831 Oral Solution</intervention_name>
    <description>10 mg dose of [14C]AZD4831 Oral Solution</description>
    <arm_group_label>[14C]AZD4831 Oral Solution</arm_group_label>
    <other_name>[14C]AZD4831</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of signed and dated written informed consent prior to any study specific&#xD;
             procedures.&#xD;
&#xD;
          2. Healthy male subjects aged 18 to 65 years inclusive at the time of signing informed&#xD;
             consent with suitable veins for cannulation or repeated venepuncture.&#xD;
&#xD;
          3. Body mass index (BMI) of 18.0 to 30.0 kg/m2 as measured at screening.&#xD;
&#xD;
          4. Must be willing and able to communicate and participate in the whole study.&#xD;
&#xD;
          5. Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools&#xD;
             per day).&#xD;
&#xD;
          6. Must agree to adhere to the contraception requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of any clinically significant disease or disorder which, in the opinion of the&#xD;
             investigator, may either put the subject at risk because of participation in the&#xD;
             study, or influence the results or the subject's ability to participate in the study.&#xD;
&#xD;
          2. History of presence of gastrointestinal, hepatic or renal disease, or any other&#xD;
             condition known to interfere with absorption, distribution, metabolism, or excretion&#xD;
             of drugs.&#xD;
&#xD;
          3. Subjects with uncontrolled or clinically significant thyroid disease as judged by the&#xD;
             investigator.&#xD;
&#xD;
          4. Any clinically significant illness, medical/surgical procedure, or trauma within 4&#xD;
             weeks of the first administration of the IMP.&#xD;
&#xD;
          5. Any clinically significant abnormalities in clinical chemistry, haematology, or&#xD;
             urinalysis results, as judged by the investigator. Subjects with known Gilbert's&#xD;
             Syndrome or persistently elevated unconjugated bilirubin are not allowed. Subjects&#xD;
             with haemoglobin &lt; lower limit of normal (LLN), white blood cell or neutrophil count&#xD;
             &lt;LLN (subjects of African origin with neutrophil count &lt;1.8 × 109/L).&#xD;
&#xD;
          6. Any clinically significant abnormal findings in vital signs, as judged by the&#xD;
             investigator. Subjects with history of orthostatic hypotension or those who are noted&#xD;
             to have a fall in systolic blood pressure &gt;/=20 mmHg or diastolic blood pressure &gt;/=10&#xD;
             mmHg and/or elevation in heart rate of more than 30 bpm or heart rate on standing&#xD;
             &gt;120/min when checked 2 min after change of posture at screening or at pre-dose.&#xD;
&#xD;
          7. Any clinically significant abnormalities on 12-lead ECG as judged by the investigator.&#xD;
&#xD;
          8. Any positive result on screening for serum hepatitis B surface antigen (HBsAg),&#xD;
             hepatitis C virus antibody, (HCV Ab) and human immunodeficiency virus (HIV) antibody.&#xD;
&#xD;
          9. Known or suspected history of drug abuse within the past 2 years, as judged by the&#xD;
             investigator.&#xD;
&#xD;
         10. Has received another new chemical entity (defined as a compound which has not been&#xD;
             approved for marketing) within 3 months of the administration of IMP in this study.&#xD;
             The period of exclusion ends three months after the final dose or 1 month after the&#xD;
             last visit whichever is the longest. Subjects who have done a 14C study in the last 12&#xD;
             months before administration of IMP. Note: subjects consented and screened, but not&#xD;
             administered IMP in this study or a previous Phase I study, are not excluded.&#xD;
&#xD;
         11. Plasma donation within 1 month of screening or any blood donation/loss more than 500&#xD;
             mL during the 3 months prior to screening.&#xD;
&#xD;
         12. Subjects with ongoing skin disorder or history of significant&#xD;
             allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity&#xD;
             to drugs with a similar chemical structure or class to AZD4831 or the formulation&#xD;
             excipients. Hay fever is allowed unless it is active.&#xD;
&#xD;
         13. Current smokers or those who have smoked or used nicotine products within the previous&#xD;
             3 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at&#xD;
             screening or admission.&#xD;
&#xD;
         14. Current users of e-cigarettes and those who have used e-cigarettes within the last 3&#xD;
             months.&#xD;
&#xD;
         15. Positive screen for drugs of abuse at screening or admission to the clinical unit or&#xD;
             positive screen for alcohol at screening or admission to the clinical unit.&#xD;
&#xD;
         16. Known or suspected history of alcohol or drug abuse or excessive intake of alcohol &gt;21&#xD;
             units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units =&#xD;
             125 mL glass of wine, depending on type)&#xD;
&#xD;
         17. Excessive intake of caffeine-containing drinks or food (e.g. coffee, tea, chocolate)&#xD;
             as judged by the investigator. Excessive intake of caffeine defined as the regular&#xD;
             consumption of more than 600 mg of caffeine per day (e.g. &gt;5 cups of coffee) or would&#xD;
             likely be unable to refrain from the use of caffeine-containing beverages during&#xD;
             confinement at the investigational site.&#xD;
&#xD;
         18. Use of drugs or supplements with enzyme-inducing properties such as St John's Wort&#xD;
             within 3 weeks prior to the first administration of IMP.&#xD;
&#xD;
         19. Use of any prescribed or non-prescribed medication including antacids, analgesics&#xD;
             (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of&#xD;
             20 to 600 times the recommended daily dose) and minerals during the two weeks prior to&#xD;
             administration of investigational product or longer if the medication has a long half&#xD;
             life. Exceptions may apply on a case by case basis, if considered not to interfere&#xD;
             with the objectives of the study, as determined by the investigator.&#xD;
&#xD;
         20. Subjects who are, or are immediate family members of, a study site or sponsor&#xD;
             employee.&#xD;
&#xD;
         21. Subjects who have previously received AZD4831.&#xD;
&#xD;
         22. Judgment by the investigator that the subject should not participate in the study if&#xD;
             they have any ongoing or recent (i.e. during the screening period) minor medical&#xD;
             complaints that may interfere with the interpretation of study data or are considered&#xD;
             unlikely to comply with study procedures, restrictions, and requirements; subjects who&#xD;
             have had fever, sore throat or flu like symptoms in the 2 weeks prior to IMP&#xD;
             administration.&#xD;
&#xD;
         23. Subjects with pregnant or lactating partners.&#xD;
&#xD;
         24. Radiation exposure, including that from the present study, excluding background&#xD;
             radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv&#xD;
             in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker,&#xD;
             as defined in the Ionising Radiation Regulations 2017, shall participate in the study&#xD;
&#xD;
         25. Evidence of renal impairment at screening, as indicated by an estimated creatinine&#xD;
             clearance of &lt;80 mL/min using the Cockcroft-Gault equation&#xD;
&#xD;
         26. Vulnerable subjects, e.g. kept in detention, protected adults under guardianship,&#xD;
             trusteeship, or committed to an institution by governmental or juridical order&#xD;
&#xD;
         27. Failure to satisfy the investigator of fitness to participate for any other reason&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Healthy male subjects</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Somasekhara Menakuru, MBBS, MS, MRCS, DPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quotient Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ruddington</city>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>August 24, 2020</last_update_submitted>
  <last_update_submitted_qc>August 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart Failure with preserved Ejection Fraction (HFpEF)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04407091
org study id: D6580C00007
nct id: NCT04407091
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Sponsor is developing the test medicine, AZD4831, for the potential treatment of
      cardiovascular disease (CVD). CVD is a general term to describe a range of conditions that
      affect the heart and blood vessels, examples of CVD include angina (chest pain caused by
      restricted blood flow to heart muscle) and heart failure (where the heart is unable to pump
      blood around the body properly). AZD4831 is an inhibitor of a protein that has a role in the
      formation of fatty deposits in arteries (blood vessels that take blood to the body). It is
      hoped that by inhibiting this action, AZD4831 will help with the management of CVD.

      The study involves radiolabelling (labelling the molecule with radioactive 14C) which is used
      to locate the molecule within the body. The study will try to assess how much radioactivity
      can be recovered from the urine and faeces (mass balance recovery) after a single oral dose
      of [14C]AZD4831. It will also look to identify the breakdown products (metabolites) of the
      parent drug. It will additionally determine the rate and route of elimination of
      [14C]AZD4831, along with the level of test medicine in the blood. The safety and tolerability
      of the test medicine will be assessed. The dose of radiation administered is very low,
      therefore the risk associated with this is very small.

      The study will consist of a single study period involving up to six healthy male volunteers.
      Up to six male volunteers will receive a dose of 10 mg of the radiolabelled test medicine as
      an oral solution. Blood, urine and faecal samples will be collected from volunteers whilst
      they are resident in the clinical unit for up to 336 hours post-dose (Day 15). A follow-up
      visit will take place seven to ten days after discharge for safety assessments.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The cumulative amount of AZD4831 excreted (CumAe)
time frame: Urine and faecal samples collected from pre-dose until 336 hours post-dose
description: Assessment of the total radioactivity by measuring the cumulative amount of AZD4831 excreted (CumAe)
measure: The cumulative amount of AZD4831 excreted and expressed as a percentage of the administered dose (CumFe)
time frame: Urine and faecal samples collected from pre-dose until 336 hours post-dose
description: Assessment of the total radioactivity by measuring the cumulative amount of AZD4831 excreted and expressed as a percentage of the administered dose (CumFe)
measure: Assessment of metabolites in plasma by accelerator mass spectrometry (AMS) analysis
time frame: Collection of plasma samples from pre-dose until 336 hours post-dose
description: Assessment of metabolites and structural identification by AMS analysis
measure: Assessment of metabolites in urine by AMS analysis
time frame: Collection of urine samples from pre-dose until 336 hours post-dose
description: Assessment of metabolites and structural identification by AMS analysis
measure: Assessment of metabolites in faeces by AMS analysis
time frame: Collection of faecal samples from pre-dose until 336 hours post-dose
description: Assessment of metabolites and structural identification by AMS analysis
measure: The amount of AZD4831 excreted (Ae)
time frame: Collection of urine and faecal samples from pre-dose to 336 hours post-dose.
description: Assessment of the rates and routes of elimination by measuring the amount excreted (Ae)
measure: Amount of AZD4831 excreted and expressed as a percentage of the administered dose (Fe)
time frame: Collection of urine and faecal samples from pre-dose to 336 hours post-dose
description: Assessment of the rates and routes of elimination by measuring the amount excreted and expressing it as a percentage of the administered dose (Fe)
measure: The cumulative amount of AZD4831 excreted (CumAe)
time frame: Collection of urine and faecal samples from pre-dose to 336 hours post-dose
description: Assessment of the rates and routes of elimination by measuring the cumulative amount excreted (CumAe)
measure: The cumulative amount of AZD4831 excreted and expressed as a percentage of the administered dose (CumFe)
time frame: Collection of urine and faecal samples from pre-dose to 336 hours post-dose
description: Assessment of the rates and routes of elimination by measuring the cumulative amount excreted and expressed as a percentage of the administered dose (CumFe)
measure: Time to maximum concentration (tmax) for AZD4831 and total radioactivity
time frame: Collection of plasma samples from pre-dose to 336 hours post-dose
description: Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the time to maximum concentration (tmax)
measure: Maximum plasma concentration (cmax) for AZD4831 and total radioactivity
time frame: Collection of plasma samples from pre-dose to 336 hours post-dose
description: Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the maximum concentration (cmax)
measure: Area under the concentration time curve from time zero to the time of the last measureable concentration (AUC0-t) for AZD4831 and total radioactivity
time frame: Collection of plasma samples from pre-dose to 336 hours post-dose
description: Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the concentration time curve from time zero to the last measureable concentration (AUC0-t)
measure: Area under the concentration time curve from time zero to the last quantifiable concentration (AUC0-inf) for AZD4831 and total radioactivity
time frame: Collection of plasma samples from pre-dose to 336 hours post-dose
description: Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the concentration time curve from time zero extrapolated to infinity (AUC0-inf)
measure: Area under the concentration time curve from time of the last measureable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC%extrap)
time frame: Collection of plasma samples from pre-dose to 336 hours post-dose
description: Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the concentration time curve from time of the last measureable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC%extrap)
measure: Apparent terminal elimination half-life (t1/2) for AZD4831 and total radioactivity
time frame: Collection of plasma samples from pre-dose to 336 hours post-dose
description: Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the terminal elimination half-life (t1/2)
measure: First order rate constant associated with the terminal (log-linear) portion of the curve for AZD4831 and total radioactivity
time frame: Collection of plasma samples from pre-dose to 336 hours post-dose
description: Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the first order rate constant associated with the terminal (log-linear) portion of the curve
measure: Total body clearance (CL/F) of AZD4831 and total radioactivity
time frame: Collection of plasma samples from pre-dose to 336 hours post-dose
description: Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring total body clearance (CL/F)
measure: Apparent volume of distribution (Vz/F) of AZD4831 and total radioactivity
time frame: Collection of plasma samples from pre-dose to 336 hours post-dose
description: Assessment of pharmacokinetics of AZD4831 and total radioactivity by measuring the apparent volume of distribution (Vz/F)
measure: Renal clearance (CLR) of AZD4831 in urine
time frame: Collection of urine samples from pre-dose to 36 hours post-dose
description: Assessment of pharmacokinetics of AZD4831 by measuring renal clearance (CLR)
measure: Evaluation of whole blood to plasma concentration ratios for total radioactivity
time frame: Collection of blood samples until 336 hours post-dose
description: Assessment of total radioactivity in whole blood and plasma
measure: Number of adverse events (AE) experienced by subjects
time frame: AEs recorded from the time of informed consent until discharge from the study (336 hours post-dose)
description: Safety and tolerability assessed through the incidence of AEs
measure: Identification of the chemical structure of major metabolite(s) in plasma
time frame: Plasma samples collected until 336 hours post-dose
description: Identification of chemical structure of major metabolites of AZD4831
measure: Identification of the chemical structure of major metabolite(s) in urine
time frame: Urine samples collected until 336 hours post-dose
description: Identification of chemical structure of major metabolites of AZD4831
measure: Identification of the chemical structure of major metabolite(s) in faeces
time frame: Faeces samples collected until 336 hours post-dose
description: Identification of chemical structure of major metabolites of AZD4831
arm group label: [14C]AZD4831 Oral Solution
arm group type: Experimental
description: One 10 mg dose of [14C]AZD4831 Oral Solution
intervention type: Drug
intervention name: 14C]AZD4831 Oral Solution
description: 10 mg dose of [14C]AZD4831 Oral Solution
arm group label: [14C]AZD4831 Oral Solution
other name: [14C]AZD4831
criteria: 
gender: Male
gender based: Yes
gender description: Healthy male subjects
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Somasekhara Menakuru, MBBS, MS, MRCS, DPM
role: Principal Investigator
affiliation: Quotient Sciences
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cardiovascular Diseases