Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants
- Registration Number
- NCT03210909
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 5
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMS-986231 Intravenous Infusion BMS-986231 A single continuous intravenous infusion of BMS-986231
- Primary Outcome Measures
Name Time Method Percent of Total Radioactivity Recovered in All Excreta (% total) Up to 8 days Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts
Total Body Clearance (CLT) Up to 8 days Measured by plasma concentrations
Time to Maximum Observed Concentration (Tmax) Up to 8 days Measured by plasma concentrations
Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) Up to 8 days Measured by plasma concentrations
Half-Life (T-HALF) Up to 8 days Measured by plasma concentrations
Volume of Distribution during Terminal Elimination Phase (Vz/F) Up to 8 days Measured by plasma concentrations
- Secondary Outcome Measures
Name Time Method Incidence of adverse events (AEs) Up to 8 days Measured by investigator assessment
Results of electrocardiogram tests (ECGs) Up to 8 days Measured by investigator assessment
Results of vital sign measurements Up to 8 days Measured by investigator assessment
Results of clinical laboratory tests Up to 8 days Measured by investigator assessment
Trial Locations
- Locations (1)
Covance Clinical Research Unit
🇺🇸Madison, Wisconsin, United States