Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants
1 other identifier
interventional
5
1 country
1
Brief Summary
An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 22, 2017
CompletedFirst Submitted
Initial submission to the registry
July 5, 2017
CompletedFirst Posted
Study publicly available on registry
July 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2017
CompletedAugust 1, 2017
July 1, 2017
28 days
July 5, 2017
July 28, 2017
Conditions
Outcome Measures
Primary Outcomes (6)
Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
Measured by plasma concentrations
Up to 8 days
Percent of Total Radioactivity Recovered in All Excreta (% total)
Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts
Up to 8 days
Half-Life (T-HALF)
Measured by plasma concentrations
Up to 8 days
Total Body Clearance (CLT)
Measured by plasma concentrations
Up to 8 days
Volume of Distribution during Terminal Elimination Phase (Vz/F)
Measured by plasma concentrations
Up to 8 days
Time to Maximum Observed Concentration (Tmax)
Measured by plasma concentrations
Up to 8 days
Secondary Outcomes (4)
Incidence of adverse events (AEs)
Up to 8 days
Results of electrocardiogram tests (ECGs)
Up to 8 days
Results of vital sign measurements
Up to 8 days
Results of clinical laboratory tests
Up to 8 days
Study Arms (1)
BMS-986231 Intravenous Infusion
EXPERIMENTALA single continuous intravenous infusion of BMS-986231
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of chronic illness
- Chronic headaches
- Recurrent dizziness
- Personal or family history of heart disease
- Personal history of bleeding diathesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance Clinical Research Unit
Madison, Wisconsin, 53704, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2017
First Posted
July 7, 2017
Study Start
June 22, 2017
Primary Completion
July 20, 2017
Study Completion
July 20, 2017
Last Updated
August 1, 2017
Record last verified: 2017-07