The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
8
200-mg (100 µCi) oral solution 14C/12C\]-fenebrutinib
Covance Clinical Research Unit, Inc
Madison, Wisconsin, United States
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Percentage of the Total Radioactive Dose Administered Excreted from Urine and Feces"; TimeFrame: "Day 1 to end of study (approximately 35 days post-dose)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any AE that can be fatal, life threatening, prolongs inpatient hospitalization, significant disability, congenital anamoly, is a significant medical event in the Investigator's judgment.
Time frame: Screening to end of study (approximately 35 days post-dose)
Maximum Observed Concentration (Cmax) of Fenebrutinib and its Metabolites
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Time to Observed Maximum Concentration (Tmax) of Fenebrutinib and its Metabolites
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) of Fenebrutinib and its Metabolites
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Area under the Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) of Fenebrutinib and its Metabolites
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Cumulative Percent of Total Radioactivity Excreted in Urine Over the Sampling Interval (Total % Feu)
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Cumulative Percent of Total Radioactivity Excreted in Feces Over the Sampling Interval (Total % Fef)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Number of Participants With Clinical Significant Changes in Vital Signs
Vital signs incudes oral temperature, respiratory rate, supine blood pressure and pulse.
Time frame: Screening up to Day 31
Number of Participants With Clinical Significant Changes in Physical Examination Findings
Physical examination will consist of an assessment of general appearance, skin, thorax/lungs, abdomen, lymph nodes, head, ears, eyes, nose, throat, neck (including thyroid); and cardiovascular, musculoskeletal, and neurological systems.
Time frame: Day -1, 28
Number of Participants With Clinical Significant Changes in Clinical Laboratory Results
Laboratory analysis include chemistry panel, complete blood count and urinalysis.
Time frame: Screnning, Day -1, 2, 4, 28
Number of Participants With Clinical Significant Changes in Electrocardiograms (ECGs)
Time frame: Screening, Day-1, 1 (Pre-dose; 1, 3 hours [h] post-dose), 28, 31