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/NCT05966324</url>
    </required_header>
    <id_info>
      <org_study_id>CIN-107-126</org_study_id>
      <nct_id>NCT05966324</nct_id>
    </id_info>
    <brief_title>Baxdrostat Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Japanese Population</brief_title>
    <official_title>A Phase 1 Single and Multiple Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Baxdrostat in Healthy Japanese and Caucasian Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AstraZeneca</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AstraZeneca</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 goal of this study is to compare the characteristics of baxdrostat (CIN-107) in terms of&#xD;
        baxdrostat levels over time in the blood in healthy Japanese and Caucasian volunteer&#xD;
        participants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Main Objectives were:&#xD;
  &#xD;
          -  To assess the safety and tolerability of single and multiple oral doses of baxdrostat in&#xD;
             healthy Japanese subjects.&#xD;
  &#xD;
          -  To assess pharmacokinetics (PK) of baxdrostat and CIN-107-M after single and multiple&#xD;
             oral doses of baxdrostat in healthy Japanese subjects.&#xD;
  &#xD;
          -  To assess pharmacodynamic (PD) effects of single and multiple oral doses of baxdrostat&#xD;
             in healthy Japanese subjects.&#xD;
  &#xD;
          -  To compare the PK and PD of baxdrostat and CIN-107-M after single and multiple oral&#xD;
             doses of baxdrostat between Japanese and Caucasian subjects.&#xD;
  &#xD;
        Participants will take baxdrostat and have their safety and blood levels of baxdrostat&#xD;
        measured over several days following single and multiple dose administration of 3 different&#xD;
        dose levels of baxdrostat. The baxdrostat blood levels over time and the levels of certain&#xD;
        hormones that regulate blood pressure will be compared between the dose groups and between&#xD;
        the healthy Japanese and Caucasian volunteer participants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 5, 2022</start_date>
    <completion_date type="Actual">September 20, 2022</completion_date>
    <primary_completion_date type="Actual">September 20, 2022</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This was a single and multiple oral dose study of the safety/tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy Japanese subjects compared with a cohort of healthy Caucasian subjects. total of 41 subjects were enrolled in this study: 31 Japanese subjects and 10 Caucasian subjects. The study included 4 cohorts and each cohort consisted of 10 subjects, randomized 4:1 (active:placebo). The Japanese cohorts (Cohorts 1, 2, and 4) were performed in parallel. The Caucasian cohort (Cohort 3) was performed after Cohort 2 was complete so that the Caucasian subjects could be matched by certain demographic factors.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>The study included 4 cohorts and each cohort consisted of 10 subjects, randomized 4:1 (active:placebo).</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of treatment emergent adverse events following single and multiple doses of baxdrostat in healthy Japanese and Caucasian participants versus placebo recipients.</measure>
      <time_frame>0 to 19 days after dosing</time_frame>
      <description>Safety and tolerability will be assessed by comparison of number of treatment emergent adverse events between groups.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the curve (AUC) for baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.</measure>
      <time_frame>0 to 15 days after dosing</time_frame>
      <description>AUC [0 to 24 hours, 0 to last quantifiable concentration, and 0 to infinity of baxdrostat] will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum Plasma Concentration [Cmax] of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.</measure>
      <time_frame>0 to 15 days after dosing</time_frame>
      <description>Cmax will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma aldosterone levels following single and multiple oral doses of baxdrostat in healthy Japanese subjects.</measure>
      <time_frame>0 to 15 days after dosing</time_frame>
      <description>Plasma aldosterone levels will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to Maximum Plasma Concentration [Tmax] of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.</measure>
      <time_frame>0 to 15 days after dosing</time_frame>
      <description>Tmax will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Terminal elimination half-life of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.</measure>
      <time_frame>0 to 15 days after dosing</time_frame>
      <description>Terminal elimination half-life will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">41</enrollment>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Oral tablet dose of baxdrostat 1 mg or placebo, administered as a single dose (Day 1) and multiple doses (once daily [QD] for 5 days, Days 6 - 10) to Japanese subjects</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Oral tablet dose of baxdrostat 3 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Japanese subjects</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Oral tablet dose of baxdrostat 3 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Caucasian subjects</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 4</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Oral tablet dose of baxdrostat 10 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Japanese subjects</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>baxdrostat</intervention_name>
      <description>Baxdrostat is an aldosterone synthase inhibitor</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>
      <other_name>CIN-107</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female subjects, 18 to 55 years of age, inclusive.&#xD;
  &#xD;
            -  Demographics as follows:&#xD;
  &#xD;
                 1. Japanese subjects must have been born in Japan, with both biological parents and&#xD;
                    all 4 biological grandparents of Japanese descent, have lived outside of Japan&#xD;
                    for &lt; 10 years, and have not significantly changed his or her diet since leaving&#xD;
                    Japan (eg, still mainly eating a &quot;Japanese&quot; diet), OR&#xD;
  &#xD;
                 2. Caucasian ancestry (Cohort 3)&#xD;
  &#xD;
            -  Healthy status as defined by absence of evidence of any active or chronic disease&#xD;
               following a detailed medical and surgical history, a complete physical examination&#xD;
               including vital signs, 12-lead ECG, and laboratory assessments (hematology, chemistry,&#xD;
               serology, and urinalysis).&#xD;
  &#xD;
            -  A BMI between 18 - 30 kg/m2, inclusive.&#xD;
  &#xD;
            -  Females may be of nonchildbearing or childbearing potential. Females of&#xD;
               nonchildbearing potential are postmenopausal or surgically sterile. Females of&#xD;
               nonchildbearing potential are exempt from the dual contraception requirement.&#xD;
  &#xD;
          Females of childbearing potential may be included, provided the subject agrees to&#xD;
          continuously use dual methods of contraception from 1 month prior through 90 days after&#xD;
          study drug administration.&#xD;
  &#xD;
            -  Able to participate and willing to give written informed consent and to comply with&#xD;
               the study restrictions.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any clinically relevant history or the presence of respiratory, renal, hepatic,&#xD;
               gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric,&#xD;
               musculoskeletal, genitourinary, immunological, dermatological, allergic,&#xD;
               ophthalmological disease or connective tissue disease, cancer or cirrhosis.&#xD;
  &#xD;
            2. A history of clinically significant drug hypersensitivity.&#xD;
  &#xD;
            3. Subjects with clinically significant symptoms of an infectious illness (bacterial,&#xD;
               viral, or parasitic) within 5 days of the first dose or a history of recurrent&#xD;
               infections.&#xD;
  &#xD;
            4. History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any&#xD;
               history of drug abuse or addiction (including soft drugs like cannabis products)&#xD;
               within 6 months of screening.&#xD;
  &#xD;
            5. Nicotine users unable or unwilling to restrict nicotine usage to the equivalent of 5&#xD;
               cigarettes daily during the study and to not smoke during the in-clinic stays.&#xD;
               (Nicotine-containing products include cigarettes, chewing tobacco, snuff, nicotine&#xD;
               patches, electronic cigarettes, vaping devices, etc.)&#xD;
  &#xD;
            6. Positive result for HIV-1 or HIV-2, hepatitis C virus (HCV), or HBsAg at screening.&#xD;
  &#xD;
            7. Confirmed (based on the average of ≥ 3 blood pressure measurements) sustained systolic&#xD;
               blood pressure &gt; 140 or &lt; 90 mmHg, and diastolic blood pressure &gt; 90 or &lt; 45 mmHg, and&#xD;
               pulse rate &gt; 100 or &lt; 40 bpm.&#xD;
  &#xD;
            8. Personal or family history of congenital long QT syndrome or QTcF values &gt; 450 msec in&#xD;
               males or &gt; 470 msec in females.&#xD;
  &#xD;
            9. Screening or baseline ECGs with QRS and/or T-wave judged by the Investigator to be&#xD;
               unfavorable for a consistently accurate QT measurement (ie, neuromuscular artifact&#xD;
               that cannot be readily eliminated, arrhythmias, indistinct QRS onset, low amplitude&#xD;
               T-wave, merged T- and U-waves, prominent U-waves, etc.)&#xD;
  &#xD;
           10. Screening or baseline ECG with clinically significant abnormalities such as atrial&#xD;
               fibrillation, atrial flutter, complete bundle branch block, Wolf-Parkinson-White&#xD;
               Syndrome, or cardiac pacemaker, as judged by the Investigator.&#xD;
  &#xD;
           11. Clinically significant abnormalities in laboratory test results (including hepatic and&#xD;
               renal panels, complete blood count, chemistry panel, and urinalysis) at screening or&#xD;
               prior to dosing. The Medical Monitor may be consulted to discuss questionable&#xD;
               abnormalities. Laboratory values that are not clinically significant, in the&#xD;
               Investigator's opinion, may be allowable. In addition, subjects with the following&#xD;
               will be excluded from the study (regardless of significance):&#xD;
  &#xD;
                 -  red blood cell count &lt; 0.75 x lower limit of normal (LLN)&#xD;
  &#xD;
                 -  white blood cell count &lt; 0.75 x LLN&#xD;
  &#xD;
                 -  hemoglobin &lt; 0.75 x LLN&#xD;
  &#xD;
                 -  aspartate transaminase &gt; 1.25 x upper limit of normal (ULN)&#xD;
  &#xD;
                 -  alanine aminotransferase &gt; 1.25 x ULN&#xD;
  &#xD;
                 -  potassium &gt; ULN&#xD;
  &#xD;
                 -  sodium &lt; LLN&#xD;
  &#xD;
               In case of questionable results, tests performed during screening or Day -2 may be&#xD;
               repeated before dosing to confirm eligibility.&#xD;
  &#xD;
           12. Subjects with estimated glomerular filtration rate &lt; 60 mL/min (according to the&#xD;
               Modification of Diet in Renal Disease formula).&#xD;
  &#xD;
           13. Subjects with clinically significant orthostatic hypotension (defined as a decrease in&#xD;
               systolic blood pressure of ≥ 20 mmHg or a decrease in diastolic blood pressure of ≥ 10&#xD;
               mmHg at 2 minutes of standing).&#xD;
  &#xD;
           14. Donation of blood &gt; 450 mL within 3 months prior to screening or plasma within 14 days&#xD;
               of dose administration.&#xD;
  &#xD;
           15. Concomitant disease or condition that could interfere with, or for which the treatment&#xD;
               thereof, might interfere with, the conduct of the study, or that would, in the opinion&#xD;
               of the Investigator, pose an unacceptable risk to the subject in this study.&#xD;
  &#xD;
           16. Known intolerance to cosyntropin test product.&#xD;
  &#xD;
           17. Use of prescription, over-the-counter, or herbal medications within 14 days prior to&#xD;
               dose administration.&#xD;
  &#xD;
           18. Participation in an investigational drug or device study within 30 days or 5&#xD;
               half-lives, whichever is longer, prior to dosing.&#xD;
  &#xD;
           19. Corticosteroid use (systemic or extensive topical use) within 3 months prior to&#xD;
               dosing.&#xD;
  &#xD;
           20. Has received a vaccination within 14 days prior to administration of the study drug.&#xD;
  &#xD;
           21. Males must agree to not donate sperm from screening through 90 days after study drug&#xD;
               administration has been completed.&#xD;
  &#xD;
           22. Strenuous activity (as assessed by the Investigator) within 48 hours prior to clinical&#xD;
               site admission.&#xD;
  &#xD;
           23. Consumption of alcohol or caffeine-containing food or beverages within 3 days prior to&#xD;
               admission to the clinical site.&#xD;
  &#xD;
           24. Involved in the planning or conduct of this study.&#xD;
  &#xD;
           25. Unwilling or unlikely to comply with the requirements of the study.&#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>Peter J Winkle, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>ICON Clinical Research LLC</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Anaheim Clinical Trials</name>
        <address>
          <city>Anaheim</city>
          <state>California</state>
          <zip>92801</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=CIN-107-126&amp;attachmentIdentifier=d22fa00b-6fa7-4160-89b5-9b41508786b5&amp;fileName=cin-107-126-synopsis_Redacted.pdf&amp;versionIdentifier=</url>
      <description>Redacted CSR Synopsis</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 4, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 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>hypertension</keyword>
    <keyword>Japanese</keyword>
    <keyword>PK</keyword>
    <keyword>baxdrostat</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. &quot;Yes&quot;, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
      <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.</ipd_access_criteria>
      <ipd_url>https://vivli.org/</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/NCT05966324
  org study id: CIN-107-126
  nct id: NCT05966324
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this study is to compare the characteristics of baxdrostat (CIN-107) in terms of
        baxdrostat levels over time in the blood in healthy Japanese and Caucasian volunteer
        participants.
  Main Objectives were:
  
          -  To assess the safety and tolerability of single and multiple oral doses of baxdrostat in
             healthy Japanese subjects.
  
          -  To assess pharmacokinetics (PK) of baxdrostat and CIN-107-M after single and multiple
             oral doses of baxdrostat in healthy Japanese subjects.
  
          -  To assess pharmacodynamic (PD) effects of single and multiple oral doses of baxdrostat
             in healthy Japanese subjects.
  
          -  To compare the PK and PD of baxdrostat and CIN-107-M after single and multiple oral
             doses of baxdrostat between Japanese and Caucasian subjects.
  
        Participants will take baxdrostat and have their safety and blood levels of baxdrostat
        measured over several days following single and multiple dose administration of 3 different
        dose levels of baxdrostat. The baxdrostat blood levels over time and the levels of certain
        hormones that regulate blood pressure will be compared between the dose groups and between
        the healthy Japanese and Caucasian volunteer participants.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This was a single and multiple oral dose study of the safety/tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy Japanese subjects compared with a cohort of healthy Caucasian subjects. total of 41 subjects were enrolled in this study: 31 Japanese subjects and 10 Caucasian subjects. The study included 4 cohorts and each cohort consisted of 10 subjects, randomized 4:1 (active:placebo). The Japanese cohorts (Cohorts 1, 2, and 4) were performed in parallel. The Caucasian cohort (Cohort 3) was performed after Cohort 2 was complete so that the Caucasian subjects could be matched by certain demographic factors.
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: The study included 4 cohorts and each cohort consisted of 10 subjects, randomized 4:1 (active:placebo).
  measure: Incidence of treatment emergent adverse events following single and multiple doses of baxdrostat in healthy Japanese and Caucasian participants versus placebo recipients.
  time frame: 0 to 19 days after dosing
  description: Safety and tolerability will be assessed by comparison of number of treatment emergent adverse events between groups.
  measure: Area under the curve (AUC) for baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
  time frame: 0 to 15 days after dosing
  description: AUC [0 to 24 hours, 0 to last quantifiable concentration, and 0 to infinity of baxdrostat] will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
  measure: Maximum Plasma Concentration [Cmax] of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
  time frame: 0 to 15 days after dosing
  description: Cmax will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
  measure: Plasma aldosterone levels following single and multiple oral doses of baxdrostat in healthy Japanese subjects.
  time frame: 0 to 15 days after dosing
  description: Plasma aldosterone levels will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
  measure: Time to Maximum Plasma Concentration [Tmax] of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
  time frame: 0 to 15 days after dosing
  description: Tmax will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
  measure: Terminal elimination half-life of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
  time frame: 0 to 15 days after dosing
  description: Terminal elimination half-life will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
  arm group label: Cohort 1
  arm group type: Experimental
  description: Oral tablet dose of baxdrostat 1 mg or placebo, administered as a single dose (Day 1) and multiple doses (once daily [QD] for 5 days, Days 6 - 10) to Japanese subjects
  arm group label: Cohort 2
  arm group type: Experimental
  description: Oral tablet dose of baxdrostat 3 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Japanese subjects
  arm group label: Cohort 3
  arm group type: Experimental
  description: Oral tablet dose of baxdrostat 3 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Caucasian subjects
  arm group label: Cohort 4
  arm group type: Experimental
  description: Oral tablet dose of baxdrostat 10 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Japanese subjects
  intervention type: Drug
  intervention name: baxdrostat
  description: Baxdrostat is an aldosterone synthase inhibitor
  arm group label: Cohort 1
  arm group label: Cohort 2
  arm group label: Cohort 3
  arm group label: Cohort 4
  other name: CIN-107
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Peter J Winkle, MD
  role: Principal Investigator
  affiliation: ICON Clinical Research LLC
  facility: 
  country: United States
  url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=CIN-107-126&attachmentIdentifier=d22fa00b-6fa7-4160-89b5-9b41508786b5&fileName=cin-107-126-synopsis_Redacted.pdf&versionIdentifier=
  description: Redacted CSR Synopsis
  responsible party type: Sponsor
  mesh term: Hypertension
  sharing ipd: Yes
  ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
  ipd access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
  ipd url: https://vivli.org/