A Study of E2086 in Healthy Men
This study is looking for healthy men aged 18 to 55 to understand how their bodies process and get rid of a drug called E2086. Participants will take an E2086 oral capsule. Researchers will measure how much of the drug is absorbed and how quickly it leaves the body over a period of up to 21 days. This helps scientists understand the drug's journey through the body. The study aims to enroll 10 participants. The current recruitment status is unclear.
- Study design
- This is an interventional study involving 10 healthy male participants. It is not specified if it is randomized or blinded.
- What's involved
- You would take an E2086 oral capsule. Researchers will collect measurements from Day 1 up to Day 21.
- Compensation
- Not stated in the trial record.
- Follow-up
- Measurements will be taken from Day 1 up to Day 21 after receiving the drug.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants
At a glance
Conditions
NCT07308236
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Fortrea Clinical Research Unit Inc.
Madison, Wisconsinno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Mass Balance Recovery of E2086, Expressed as Cumulative Percent of the Radiolabeled DoseDay 1 up to Day 21
Mass balance will be determined by pharmacokinetic (PK) analysis of \[14C\]E2086 and E2086 in the biological matrices.
- Maximum Observed Concentration (Cmax) of [14C]E2086 for Total Radioactivity (TRA) in PlasmaDay 1 up to Day 21
- Time to Reach Cmax (Tmax) of [14C]E2086 for TRA in PlasmaDay 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 PlasmaDay 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 PlasmaDay 1 up to Day 21
- Terminal Elimination Phase Half-life (t1/2) of [14C]E2086 for TRA in PlasmaDay 1 up to Day 21
- Cmax of [14C]E2086 for TRA in Whole BloodDay 1 up to Day 21
- Tmax of [14C]E2086 for TRA in Whole BloodDay 1 up to Day 21
- AUC (0-t) of [14C]E2086 for TRA in Whole BloodDay 1 up to Day 21
- AUC (0-inf) of [14C]E2086 for TRA in Whole BloodDay 1 up to Day 21
- t1/2 of [14C]E2086 for TRA in Whole BloodDay 1 up to Day 21
- Cmax of E2086 and its Metabolite M1 in Plasma Using liquid Chromatography Coupled With Mass Spectrometry (LC-MS/MS)Day 1 up to Day 21
- Tmax E2086 and its Metabolite M1 in Plasma Using LC-MS/MSDay 1 up to Day 21
- AUC (0-t) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MSDay 1 up to Day 21
- AUC (0-inf) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MSDay 1 up to Day 21
- t1/2 of E2086 and its Metabolite M1 in Plasma Using LC-MS/MSDay 1 up to Day 21
- Apparent Total Clearance (CL/F) of E2086 in Plasma Using LC-MS/MSDay 1 up to Day 21
- Apparent Volume of Distribution (Vz/F) at Terminal Phase of E2086 in Plasma Using LC-MS/MSDay 1 up to Day 21
- Metabolite Ratio (MRp) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MSDay 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/MSDay 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/MSDay 1 up to Day 21
- Renal Clearance (CLR) of E2086 and its Metabolite M1 in Urine Using LC-MS/MSDay 1 up to Day 21
- MRu of E2086 and its Metabolite M1 in Urine Using LC-MS/MSDay 1 up to Day 21
- Percentage of Administered Radioactive Dose Excreted in Urine, Feces, and Toilet Tissue by TRADay 1 up to Day 21