A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants
← catalyst calendarSponsored by Eisai Inc. (industry) · 4523.T — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Na · None · Basic science
Enrollment
10estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-12-31 | actual | When the study began enrolling |
| Primary completion | 2026-02-23 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-02-23 | estimated | The whole study's end, after follow-up |
| First posted | 2025-12-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteers
Intervention
- Drug: E2086
Primary outcomes
what the primary-completion date above is the date OFMass Balance Recovery of E2086, Expressed as Cumulative Percent of the Radiolabeled Dose
measured Day 1 up to Day 21
Maximum Observed Concentration (Cmax) of [14C]E2086 for Total Radioactivity (TRA) in Plasma
measured Day 1 up to Day 21
Time to Reach Cmax (Tmax) of [14C]E2086 for TRA in Plasma
measured 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
measured 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
measured Day 1 up to Day 21
Terminal Elimination Phase Half-life (t1/2) of [14C]E2086 for TRA in Plasma
measured Day 1 up to Day 21
Cmax of [14C]E2086 for TRA in Whole Blood
measured Day 1 up to Day 21
Tmax of [14C]E2086 for TRA in Whole Blood
measured Day 1 up to Day 21
AUC (0-t) of [14C]E2086 for TRA in Whole Blood
measured Day 1 up to Day 21
AUC (0-inf) of [14C]E2086 for TRA in Whole Blood
measured Day 1 up to Day 21
t1/2 of [14C]E2086 for TRA in Whole Blood
measured 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)
measured Day 1 up to Day 21
Tmax E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
measured Day 1 up to Day 21
AUC (0-t) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
measured Day 1 up to Day 21
AUC (0-inf) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
measured Day 1 up to Day 21
t1/2 of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
measured Day 1 up to Day 21
Apparent Total Clearance (CL/F) of E2086 in Plasma Using LC-MS/MS
measured Day 1 up to Day 21
Apparent Volume of Distribution (Vz/F) at Terminal Phase of E2086 in Plasma Using LC-MS/MS
measured Day 1 up to Day 21
Metabolite Ratio (MRp) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
measured 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
measured 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
measured Day 1 up to Day 21
Renal Clearance (CLR) of E2086 and its Metabolite M1 in Urine Using LC-MS/MS
measured Day 1 up to Day 21
MRu of E2086 and its Metabolite M1 in Urine Using LC-MS/MS
measured Day 1 up to Day 21
Percentage of Administered Radioactive Dose Excreted in Urine, Feces, and Toilet Tissue by TRA
measured Day 1 up to Day 21
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