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/NCT06027437</url>
    </required_header>
    <id_info>
      <org_study_id>CV028-1012</org_study_id>
      <nct_id>NCT06027437</nct_id>
    </id_info>
    <brief_title>A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants</brief_title>
    <official_title>A Phase 1, Open-label, Randomized, Single-dose, 3-Period, 3-Sequence Crossover Study to Assess the Relative Bioavailability of the Intended Commercial Formulation Versus the Previous MyoKardia Formulation of Danicamtiv and to Assess the Effect of Food on the Pharmacokinetics of the Intended Commercial Formulation in Healthy Adult Participants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bristol-Myers Squibb</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bristol-Myers Squibb</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 purpose of this study is to assess the relative biological availability and the effect of&#xD;
        food on the drug levels of Danicamtiv in health adults.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 6, 2023</start_date>
    <completion_date type="Anticipated">November 9, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 9, 2023</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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum observed plasma concentration (Cmax)</measure>
      <time_frame>Up to day 16</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF))</measure>
      <time_frame>Up to day 16</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))</measure>
      <time_frame>Up to day 16</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time of maximum observed plasma concentration (Tmax)</measure>
      <time_frame>Up to day 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal elimination half-life (T-HALF)</measure>
      <time_frame>Up to day 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent total body clearance (CLT/F)</measure>
      <time_frame>Up to day 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent volume of distribution (Vz/F)</measure>
      <time_frame>Up to day 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with Adverse Events (AEs)</measure>
      <time_frame>Up to day 43</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with Serious Adverse Events (SAEs)</measure>
      <time_frame>Up to day 43</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with vital sign abnormalities</measure>
      <time_frame>Up to day 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with Electrocardiogram (ECG) abnormalities</measure>
      <time_frame>Up to day 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with Physical Examination (PE) abnormalities</measure>
      <time_frame>Up to day 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with clinical laboratory abnormalities</measure>
      <time_frame>Up to day 16</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">21</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Treatment A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Danicamtiv</intervention_name>
      <description>Specified dose on specified days.</description>
      <arm_group_label>Treatment A</arm_group_label>
      <arm_group_label>Treatment B</arm_group_label>
      <arm_group_label>Treatment C</arm_group_label>
      <other_name>BMS-986434</other_name>
      <other_name>MYK-491</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 inclusive&#xD;
  &#xD;
            -  Participants with resting heart rate ≥ 55 bpm&#xD;
  &#xD;
            -  Seasonal allergies that do not require medication at the time of the study are&#xD;
               acceptable&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any acute or chronic medical illness&#xD;
  &#xD;
            -  Head injury, intracranial tumor, or aneurysm within 2 years prior to screening&#xD;
  &#xD;
            -  History of chronic gastrointestinal disorders or gastrointestinal (GI) surgery&#xD;
               (including cholecystectomy) that could impact on drug and food absorption and/or drug&#xD;
               excretion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bristol-Myers Squibb</last_name>
      <role>Study Director</role>
      <affiliation>Bristol-Myers Squibb</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>BMS Study Connect www.BMSStudyConnect.com</last_name>
      <phone>855-907-3286</phone>
      <email>Clinical.Trials@bms.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>First line of the email MUST contain the NCT# and Site#</last_name>
    </overall_contact_backup>
    <link>
      <url>http://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
      <description>BMS Clinical Trial Information</description>
    </link>
    <link>
      <url>http://www.BMSStudyConnect.com</url>
      <description>BMS Clinical Trial Patient Recruiting</description>
    </link>
    <link>
      <url>http://www.fda.gov/safety/medwatch/safetyinformation/default.htm</url>
      <description>FDA Safety Alerts and Recalls</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>BMS-986434</keyword>
    <keyword>MYK-491</keyword>
    <keyword>Healthy</keyword>
    <keyword>Biological Availability</keyword>
    <keyword>Food Effect</keyword>
    <!-- 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/NCT06027437
  org study id: CV028-1012
  nct id: NCT06027437
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to assess the relative biological availability and the effect of
        food on the drug levels of Danicamtiv in health adults.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Maximum observed plasma concentration (Cmax)
  time frame: Up to day 16
  measure: Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF))
  time frame: Up to day 16
  measure: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
  time frame: Up to day 16
  measure: Time of maximum observed plasma concentration (Tmax)
  time frame: Up to day 16
  measure: Terminal elimination half-life (T-HALF)
  time frame: Up to day 16
  measure: Apparent total body clearance (CLT/F)
  time frame: Up to day 16
  measure: Apparent volume of distribution (Vz/F)
  time frame: Up to day 16
  measure: Number of participants with Adverse Events (AEs)
  time frame: Up to day 43
  measure: Number of participants with Serious Adverse Events (SAEs)
  time frame: Up to day 43
  measure: Number of participants with vital sign abnormalities
  time frame: Up to day 16
  measure: Number of participants with Electrocardiogram (ECG) abnormalities
  time frame: Up to day 16
  measure: Number of participants with Physical Examination (PE) abnormalities
  time frame: Up to day 16
  measure: Number of participants with clinical laboratory abnormalities
  time frame: Up to day 16
  arm group label: Treatment A
  arm group type: Experimental
  arm group label: Treatment B
  arm group type: Experimental
  arm group label: Treatment C
  arm group type: Experimental
  intervention type: Drug
  intervention name: Danicamtiv
  description: Specified dose on specified days.
  arm group label: Treatment A
  arm group label: Treatment B
  arm group label: Treatment C
  other name: BMS-986434
  other name: MYK-491
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bristol-Myers Squibb
  role: Study Director
  affiliation: Bristol-Myers Squibb
  last name: BMS Study Connect www.BMSStudyConnect.com
  phone: 855-907-3286
  email: Clinical.Trials@bms.com
  last name: First line of the email MUST contain the NCT# and Site#
  url: http://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
  description: BMS Clinical Trial Information
  url: http://www.BMSStudyConnect.com
  description: BMS Clinical Trial Patient Recruiting
  url: http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
  description: FDA Safety Alerts and Recalls
  responsible party type: Sponsor