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
About this trial
This is an interventional treatment trial for Heart Failure
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
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
NCT ID
NCT02819271
First Posted
June 28, 2016
Last Updated
January 19, 2017
Sponsor
Bristol-Myers Squibb
Collaborators
Cardioxyl Pharmaceuticals, Inc
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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