The primary purpose of this study is to determine the metabolism and excretion of \[14C\]E2086 in healthy male participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
E2086 oral capsule.
Fortrea Clinical Research Unit Inc.
Madison, Wisconsin, United States
Mass Balance Recovery of E2086, Expressed as Cumulative Percent of the Radiolabeled Dose
Mass balance will be determined by pharmacokinetic (PK) analysis of \[14C\]E2086 and E2086 in the biological matrices.
Time frame: Day 1 up to Day 21
Maximum Observed Concentration (Cmax) of [14C]E2086 for Total Radioactivity (TRA) in Plasma
Time frame: Day 1 up to Day 21
Time to Reach Cmax (Tmax) of [14C]E2086 for TRA in Plasma
Time frame: Day 1 up to Day 21
Area Under the Concentration-time Curve from Zero Time to Time of Last Quantifiable Concentration [AUC (0-t)] of [14C]E2086 for TRA in Plasma
Time frame: Day 1 up to Day 21
Area Under the Concentration-time Curve from Zero Time Extrapolated to Infinite Time [AUC (0-inf)] of [14C]E2086 for TRA in Plasma
Time frame: Day 1 up to Day 21
Terminal Elimination Phase Half-life (t1/2) of [14C]E2086 for TRA in Plasma
Time frame: Day 1 up to Day 21
Cmax of [14C]E2086 for TRA in Whole Blood
Time frame: Day 1 up to Day 21
Tmax of [14C]E2086 for TRA in Whole Blood
Time frame: Day 1 up to Day 21
AUC (0-t) of [14C]E2086 for TRA in Whole Blood
Time frame: Day 1 up to Day 21
AUC (0-inf) of [14C]E2086 for TRA in Whole Blood
Time frame: Day 1 up to Day 21
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
t1/2 of [14C]E2086 for TRA in Whole Blood
Time frame: Day 1 up to Day 21
Cmax of E2086 and its Metabolite M1 in Plasma Using liquid Chromatography Coupled With Mass Spectrometry (LC-MS/MS)
Time frame: Day 1 up to Day 21
Tmax E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Time frame: Day 1 up to Day 21
AUC (0-t) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Time frame: Day 1 up to Day 21
AUC (0-inf) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Time frame: Day 1 up to Day 21
t1/2 of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Time frame: Day 1 up to Day 21
Apparent Total Clearance (CL/F) of E2086 in Plasma Using LC-MS/MS
Time frame: Day 1 up to Day 21
Apparent Volume of Distribution (Vz/F) at Terminal Phase of E2086 in Plasma Using LC-MS/MS
Time frame: Day 1 up to Day 21
Metabolite Ratio (MRp) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Time frame: Day 1 up to Day 21
Cumulative Amount Excreted in Urine from Zero Time to Time of Last Interval (Ae) of E2086 and its Metabolite M1 in Urine Using LC-MS/MS
Time frame: Day 1 up to Day 21
Fraction of Dose Excreted in Urine from Zero Time to Time of Last Interval (Fe) of E2086 and its Metabolite M1 in Urine Using LC-MS/MS
Time frame: Day 1 up to Day 21
Renal Clearance (CLR) of E2086 and its Metabolite M1 in Urine Using LC-MS/MS
Time frame: Day 1 up to Day 21
MRu of E2086 and its Metabolite M1 in Urine Using LC-MS/MS
Time frame: Day 1 up to Day 21
Percentage of Administered Radioactive Dose Excreted in Urine, Feces, and Toilet Tissue by TRA
Time frame: Day 1 up to Day 21
Characterization of Metabolites in Plasma, Urine, Feces After Administration of a Single Oral Dose of Radiolabeled [14C]E2086
Metabolite profiling in plasma, urine, and feces will be performed by radio-high performance liquid chromatography (HPLC) methods and/or accelerator mass spectrometry. Metabolites (M1) and other metabolites will be identified and estimated on the radiochromatograms, and the amount of each metabolite will be quantified based on the peak areas on the radiochromatograms. For metabolites detected on the radiochromatograms, LC-MS/MS analysis may be performed to estimate and identify their chemical structures.
Time frame: Up to 21 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 21 days
Number of Participants With Abnormal Laboratory Parameter Values
Time frame: Up to 21 days
Number of Participants With Clinically Significant Change in Vital Sign Values
Time frame: Up to 21 days
Number of Participants With Clinically Significant Change in 12-Lead Electrocardiogram (ECG) Values
Time frame: Up to 21 days