About this trial
The primary purpose of this study is to determine the metabolism and excretion of \[14C\]E2086 in healthy male participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Non-smoking and non-vaping, healthy male, age greater than or equal to (>=) 18 years and less than or equal to (<=) 55 years old at the time of informed consent
Body Mass Index (BMI) >=18 and less than (<) 30 kilogram per square meter (kg/m²) at Screening
Provide written informed consent
Willing and able to comply with all aspects of the protocol
Disqualifiers
Have previously been dosed in more than 2 radiolabeled drug studies in the past 12 months. For participants who have previously been dosed in 2 or more radiolabeled drug studies within the last 12 months, the previous radiolabeled dose must be at least 4 months prior to check-in to the trial site where exposures are known to the investigator, or 6 months prior to check-in to the trial site for a radiolabeled drug trial where exposures are not known to the investigator. The total 12-month exposure from this trial and a maximum of 2 other previous radiolabeled studies must be within the CFR recommended levels considered safe, per US Title 21 CFR 361.1.
Exposure to significant diagnostic or therapeutic radiation (eg, serial x-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the following criteria: not of childbearing potential or practicing highly effective contraception throughout the trial period and for 28 days after trial drug discontinuation. No sperm donation is allowed during the trial period and for 90 days after trial drug discontinuation.
Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
Trial design
Single group
Treatments tested in this trial
E2086
DrugE2086 oral capsule.
Treatment groups
Trial outcomes
Primary outcomes
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.
Maximum Observed Concentration (Cmax) of [14C]E2086 for Total Radioactivity (TRA) in Plasma
Time to Reach Cmax (Tmax) of [14C]E2086 for TRA in Plasma
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
Secondary outcomes
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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of Participants With Abnormal Laboratory Parameter Values
Number of Participants With Clinically Significant Change in Vital Sign Values