An Open-label, Single-dose Study to Determine the Metabolism and Excretion of [14C]E2006 in Healthy Male Subjects
- Registration Number
- NCT02046213
- Lead Sponsor
- Eisai Inc.
- Brief Summary
The purpose of this study is to determine the metabolism and excretion of \[14C\]E2006 in healthy male subjects.
- Detailed Description
This is an open-label, single-dose study in healthy male subjects. The study will have 2 phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will consist of a Screening Period and a Baseline Period, during which each subject's eligibility will be determined and assessments will be conducted.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description E2006 E2006 Single oral 10mg dose of 100 uCi \[14C\]E2006
- Primary Outcome Measures
Name Time Method Pharmacokinetics: Excretion of E2006: urine/feces concentration Up to 35 days Total radioactivity derived from \[14C\]E2006-related material and E2006 will be analyzed in urine and feces. \[14C\]E2006 radiolabeled material will be quantified in urine and feces for total radioactivity using a scintillation counting method and/or an accelerator mass spectrometry.
Pharmacokinetics: Plasma concentration of E2006/metabolite Up to 816 hours postdose Total radioactivity derived from \[14C\]E2006-related material, E2006, and metabolites will be analyzed in whole blood, plasma, and red blood cells. \[14C\]E2006 radiolabeled material will be quantified in whole blood, plasma, red blood cells for total radioactivity using a scintillation counting method and/or accelerator mass spectrometry.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: Metabolic profile of E2006: plasma/urine/feces concentration Urine/Feces: Up to 35 days; Plasma: Up to 816 hours postdose Metabolite profiling in plasma, urine, and feces will be performed by radio-high performance liquid chromatography (radio-HPLC) methods. Metabolites will be identified on the radiochromatograms, and the amount of the each metabolite will be quantified based on the peak areas on the chromatograms. For metabolites detected on the radiochromatograms, LC/MS/MS analysis will be performed to estimate and identify their chemical structures.
Trial Locations
- Locations (1)
Covance Clinical Research Unit
🇺🇸Madison, Wisconsin, United States