The primary objective of this study is to characterize the metabolic disposition, pharmacokinetics (PK), and routes of elimination of \[14C\]-labeled BVD-523 after administration of a single, oral dose to healthy male subjects. The secondary objective of this study is to evaluate the safety and tolerability of a single oral dose of \[14C\]-labeled BVD-523 in healthy male subjects.
This study will be an open-label, absorption, metabolism, and excretion study of \[14C\]-BVD-523 administered as a 600-mg (approximately 200 µCi) oral dose to 6 healthy male subjects following a 2-hour fast from food (not including water) that follows breakfast.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
\[14C\]-BVD-523 administered as a 600-mg (approximately 200 µCi) oral dose to 6 healthy male subjects following a 2-hour fast from food (not including water) that follows breakfast.
Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) Tmax
Time to peak concentration (Tmax), PK blood samples were taken at the following time points 0 (predose), 30 min, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose.
Time frame: Collected over 5 days
Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) Cmax
peak (maximum) concentration
Time frame: Collected over 5 days
Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) t1/2
Elimination half-life
Time frame: Collected over 15 days
Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) AUC
Area under Curve (AUC), 0-24 hr
Time frame: Collected over 15 dyas
Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) CL/F
Oral Clearance (CL/F)
Time frame: Collected over 15 days
Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) V/F
Apparent volume of distribution (V/F)
Time frame: Collected over 15 days
Excretion Rate of 14C-labeled BVD-523(Radioactivity in Feces)
Percent of dose excreted in feces
Time frame: Collected over 15 days
Excretion Rate of 14C-labeled BVD-523(Radioactivity in Urine)
Percent of dose excreted in urine
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Time frame: Collected over 15 days
Cumulative Whole Blood: Plasma Ratio Calculated for AUC0-12
AUC from time zero to the 12 hr time point with concentration above the lower limit of quantitation
Time frame: Collected in 12 hrs
Cumulative Whole Blood: Plasma Ratio Calculated for AUC 0-24
AUC from time zero to 24 hrs
Time frame: Collected in 24 hrs
Treatment-related Adverse Events
Any treatment-emergent adverse events related or likely related to study treatment
Time frame: 27 days