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The primary objective of the study is to achieve mass balance recovery of [14C]-radiolabel in urine and feces and to identify and quantify the main elimination pathways of E2027.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2027 | Experimental | Participants will receive approximately 130 microcurie (μCi) of [14C]E2027 as a single 50 milligram (mg) (free base), capsule, orally on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2027 | Drug | E2027 oral capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Percent of the Radiolabeled Dose of [14C]E2027 in Biological Matrices (Blood, Urine, Feces and Toilet Tissue) | Blood, urine, feces and toilet tissue samples will be collected at specific time points and will be analyzed for the amount of radiolabeled [14C]E2027. | Up to 56 days |
| Maximum Concentration (Cmax) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices | Pre-dose up to Day 56 post-dose | |
| Time to Reach Maximum (Peak) Concentration (Tmax) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices | Pre-dose up to Day 56 post-dose | |
| Area Under the Concentration-Time Curve From Time Zero to 24 hours (AUC(0-24h)) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices | Pre-dose up to Day 56 post-dose | |
| Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC(0-t)) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices | Pre-dose up to Day 56 post-dose | |
| Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC(0-inf)) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices | Pre-dose up to Day 56 post-dose | |
| Terminal Elimination Half-life (t1/2) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices | Pre-dose up to Day 56 post-dose | |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 56 days post-dose | |
| Number of Participants With Clinically Significant Abnormal Laboratory Values | Up to 56 days post-dose |
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Inclusion Criteria:
Participants must meet all of the following criteria to be included in this study:
1. Body Mass Index (BMI) of 18 to 30 kilogram per square meter (kg/m^2) at Screening
Exclusion Criteria
Participants who meet any of the following criteria will be excluded from this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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| ID | Term |
|---|---|
| D020961 | Lewy Body Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Apparent Total Body Clearance (CL/F) of E2027 in Biological Matrices |
| Pre-dose up to Day 56 post-dose |
| Apparent Volume of Distribution (Vd/F) of E2027 in Biological Matrices | Pre-dose up to Day 28 post-dose |
| Percent of AUC(0-inf) of Metabolite to E2027 in Biological Matrices | Pre-dose up to Day 28 post-dose |
| Number of Participants With Clinically Significant Abnormal Vital Sign Values | Up to 56 days post-dose |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | Up to 56 days post-dose |
| Number of Participants With Clinically Significant Abnormal Physical Examination Findings | Baseline, Up to 56 days post-dose |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |