This is an open-label, single dose study in healthy male subjects.
A baseline (predose) fecal sample and a baseline (predose) urine sample will be obtained at the clinic prior to dosing on Day 1. On Day 1, subjects will begin the Treatment Phase. Subjects will be released from the clinic after at least 10 days since dosing and as soon as the following conditions are met: * greater than 90% of the administered radioactivity has been recovered, and * less than 1% of the administered radioactive dose is recovered in two consecutive 24-hour samples each of urine and feces
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
113
Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance
Covance Clinical Research Unit Inc.
Madison, Wisconsin, United States
Covance Laboratories
Madison, Wisconsin, United States
Pharmacokinetics: Elimination of E2609: urine/feces concentration
Total radioactivity will be analyzed in urine and feces predose and up to 28 days postdose.
Time frame: Predose and every 24 hours postdose up to 28 days
Pharmacokinetics: Plasma concentration of E2609/metabolite
Total radioactivity will be analyzed in whole blood, plasma, and red blood cells.
Time frame: Predose andup to 648 hours postdose
Pharmacokinetics: Metabolic profile of E2609: plasma/urine/feces concentration
Metabolite profiling in plasma, urine, and feces will be performed by liquid chromatography with radiodetection (radio-high performance liquid chromatography \[HPLC\]) methods. A scintillation counter and/or AMS will be used to detect radioactivity. If needed, plasma and feces samples will be treated with cysteine and/or other reagents before radio-HPLC analyses.
Time frame: Predose andup to 648 hours postdose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.