Back to resultsPharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants
Primary Purpose
Heart Decompensation, Acute
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986231
Sponsored by
About this trial
This is an interventional treatment trial for Heart Decompensation, Acute
Eligibility Criteria
Inclusion Criteria:
- Signed Informed Consent
- Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
- Body weight between 75 and 95 kg, inclusive; body mass index (BMI) between 18 to 32 kg/m2.
Exclusion Criteria:
- History of chronic illness
- Chronic headaches
- Recurrent dizziness
- Personal or family history of heart disease
- Personal history of bleeding diathesis
Other protocol defined inclusion/exclusion criteria could apply
Sites / Locations
- Covance Clinical Research Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BMS-986231 Intravenous Infusion
Arm Description
A single continuous intravenous infusion of BMS-986231
Outcomes
Primary Outcome Measures
Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
Measured by plasma concentrations
Percent of Total Radioactivity Recovered in All Excreta (% total)
Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts
Half-Life (T-HALF)
Measured by plasma concentrations
Total Body Clearance (CLT)
Measured by plasma concentrations
Volume of Distribution during Terminal Elimination Phase (Vz/F)
Measured by plasma concentrations
Time to Maximum Observed Concentration (Tmax)
Measured by plasma concentrations
Secondary Outcome Measures
Incidence of adverse events (AEs)
Measured by investigator assessment
Results of electrocardiogram tests (ECGs)
Measured by investigator assessment
Results of vital sign measurements
Measured by investigator assessment
Results of clinical laboratory tests
Measured by investigator assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03210909
Brief Title
Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants
Official Title
Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 22, 2017 (Actual)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
July 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Decompensation, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-986231 Intravenous Infusion
Arm Type
Experimental
Arm Description
A single continuous intravenous infusion of BMS-986231
Intervention Type
Drug
Intervention Name(s)
BMS-986231
Intervention Description
BMS-986231
Primary Outcome Measure Information:
Title
Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
Description
Measured by plasma concentrations
Time Frame
Up to 8 days
Title
Percent of Total Radioactivity Recovered in All Excreta (% total)
Description
Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts
Time Frame
Up to 8 days
Title
Half-Life (T-HALF)
Description
Measured by plasma concentrations
Time Frame
Up to 8 days
Title
Total Body Clearance (CLT)
Description
Measured by plasma concentrations
Time Frame
Up to 8 days
Title
Volume of Distribution during Terminal Elimination Phase (Vz/F)
Description
Measured by plasma concentrations
Time Frame
Up to 8 days
Title
Time to Maximum Observed Concentration (Tmax)
Description
Measured by plasma concentrations
Time Frame
Up to 8 days
Secondary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Description
Measured by investigator assessment
Time Frame
Up to 8 days
Title
Results of electrocardiogram tests (ECGs)
Description
Measured by investigator assessment
Time Frame
Up to 8 days
Title
Results of vital sign measurements
Description
Measured by investigator assessment
Time Frame
Up to 8 days
Title
Results of clinical laboratory tests
Description
Measured by investigator assessment
Time Frame
Up to 8 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Signed Informed Consent
Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
Body weight between 75 and 95 kg, inclusive; body mass index (BMI) between 18 to 32 kg/m2.
Exclusion Criteria:
History of chronic illness
Chronic headaches
Recurrent dizziness
Personal or family history of heart disease
Personal history of bleeding diathesis
Other protocol defined inclusion/exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Covance Clinical Research Unit
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants
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