The purpose of this study is to determine the absorption, metabolism, and excretion of \[14C\]-BGB-16673 and to characterize and determine, where possible, the metabolites present in plasma, urine, and feces in healthy male participants following a single oral administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Administered orally as suspension in lipid vehicle
Fortrea Clinical Research Unit Inc
Madison, Wisconsin, United States
Total Radioactivity Recovery (fet1-t2) in Urine and Feces
Time frame: Approximately 35 Days
Area Under the Plasma Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673
Time frame: Approximately 35 Days
Area Under the Plasma Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) for Total Radioactivity in Plasma and Whole Blood
Time frame: Approximately 35 Days
Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of BGB-16673
Time frame: Approximately 35 Days
Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) for Total Radioactivity in Plasma and Whole Blood
Time frame: Approximately 35 Days
Maximum Observed Plasma Concentration (Cmax) of BGB-16673
Time frame: Approximately 35 Days
Maximum Observed Plasma Concentration (Cmax) for Total Radioactivity in Plasma and Whole Blood
Time frame: Approximately 35 Days
Time of the Maximum Observed Plasma Concentration (Tmax) of BGB-16673
Time frame: Approximately 35 Days
Time of the Maximum Observed Plasma Concentration (Tmax) for Total Radioactivity in Plasma and Whole Blood
Time frame: Approximately 35 Days
Apparent Terminal Elimination Half-life (t1/2) of BGB-16673
Time frame: Approximately 35 Days
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Apparent Terminal Elimination Half-life (t1/2) for Total Radioactivity in Plasma and Whole Blood
Time frame: Approximately 35 Days
Urinary recovery of BGB-16673 (fet1-t2)
Time frame: Approximately 35 Days
Quantitative metabolic profiles of BGB-16673 in plasma and excreta
Time frame: Approximately 35 Days
Identification of BGB-16673 major metabolites in plasma and excreta
Time frame: Approximately 35 Days
Number of Participants with Adverse Events (AEs)
Time frame: Approximately 35 days
Number of Participants with Clinically Significant Laboratory Values
Time frame: Approximately 9 weeks
Number of Participants with Clinically Significant Electrocardiogram (ECG) Results
Time frame: Approximately 9 weeks
Number of Participants with Clinically Significant Vital Sign Measurements
Time frame: Approximately 9 weeks