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A First-in-Human Study of the Safety of Single Continuous Intravenous (IV) Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CXL-1427 Ascending Dose
Placebo
CXL-1427 Descending Dose
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • No evidence of any acute or chronic health disorder
  • Not have taken any prescription medication within 15 days of study entry
  • Not have taken any over-the-counter medication or herbal/vitamin supplement within 3 days of study entry
  • Not have not have any dietary restrictions
  • Have a body mass index (BMI) of ≥18 to ≤34
  • Weigh at least 50kg (110 pounds)

Exclusion Criteria:

  • Be a current or recent (within 6 months of the Screening Visit) smoker or user of any nicotine-containing product
  • Have a history of symptomatic hypotension, orthostatic hypotension or syncope
  • Have a history of headaches or other symptoms attributable to caffeine withdrawal
  • Have a history of any bleeding diathesis
  • Have a positive serology screen for HIV antibody, hepatitis B surface antigen or hepatitis C antibody at screening

Other protocol defined inclusion/exclusion criteria could apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    CXL-1427 (BMS-986231)

    Placebo

    Arm Description

    Experimental

    Placebo

    Outcomes

    Primary Outcome Measures

    Safety measured by percentage of Treatment Emergent Adverse Events (TEAEs)
    Tolerability measured by percentage of Treatment Emergent Adverse Events (TEAEs)

    Secondary Outcome Measures

    Steady-state plasma concentration (Css)
    Area under the plasma concentration (AUC) vs. time curve
    Terminal elimination half-life (1/2)
    Total body clearance (CL)
    Steady-state volume of distributions (Vss)
    Time to Css

    Full Information

    First Posted
    June 28, 2016
    Last Updated
    January 19, 2017
    Sponsor
    Bristol-Myers Squibb
    Collaborators
    Cardioxyl Pharmaceuticals, Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02819271
    Brief Title
    A First-in-Human Study of the Safety of Single Continuous Intravenous (IV) Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers
    Official Title
    A First-in-Human Study of the Safety of Single Continuous Intravenous Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bristol-Myers Squibb
    Collaborators
    Cardioxyl Pharmaceuticals, Inc

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy volunteers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CXL-1427 (BMS-986231)
    Arm Type
    Experimental
    Arm Description
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    CXL-1427 Ascending Dose
    Other Intervention Name(s)
    BMS-986231
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    CXL-1427 Descending Dose
    Other Intervention Name(s)
    BMS-986231
    Primary Outcome Measure Information:
    Title
    Safety measured by percentage of Treatment Emergent Adverse Events (TEAEs)
    Time Frame
    Up to 31 days
    Title
    Tolerability measured by percentage of Treatment Emergent Adverse Events (TEAEs)
    Time Frame
    Up to 31 days
    Secondary Outcome Measure Information:
    Title
    Steady-state plasma concentration (Css)
    Time Frame
    Up to 4 days
    Title
    Area under the plasma concentration (AUC) vs. time curve
    Time Frame
    Up to 4 days
    Title
    Terminal elimination half-life (1/2)
    Time Frame
    Up to 4 days
    Title
    Total body clearance (CL)
    Time Frame
    Up to 4 days
    Title
    Steady-state volume of distributions (Vss)
    Time Frame
    Up to 4 days
    Title
    Time to Css
    Time Frame
    Up to 4 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: No evidence of any acute or chronic health disorder Not have taken any prescription medication within 15 days of study entry Not have taken any over-the-counter medication or herbal/vitamin supplement within 3 days of study entry Not have not have any dietary restrictions Have a body mass index (BMI) of ≥18 to ≤34 Weigh at least 50kg (110 pounds) Exclusion Criteria: Be a current or recent (within 6 months of the Screening Visit) smoker or user of any nicotine-containing product Have a history of symptomatic hypotension, orthostatic hypotension or syncope Have a history of headaches or other symptoms attributable to caffeine withdrawal Have a history of any bleeding diathesis Have a positive serology screen for HIV antibody, hepatitis B surface antigen or hepatitis C antibody at screening Other protocol defined inclusion/exclusion criteria could apply
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cardioxyl Pharmaceuticals
    Organizational Affiliation
    Cardioxyl Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A First-in-Human Study of the Safety of Single Continuous Intravenous (IV) Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers

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