Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704, United States
NCT Number: NCT04023877
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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Notify Me18 year–55 year
Male
Interventional
Phase 1
Madison, Wisconsin, 53704, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants must meet all of the following criteria to be included in this study:
Exclusion criteria
Participants who meet any of the following criteria will be excluded from this study:
E2027 oral capsule.
Time frame: Up to 56 days
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.
Time frame: Pre-dose up to Day 56 post-dose
Time frame: Pre-dose up to Day 56 post-dose
Time frame: Pre-dose up to Day 56 post-dose
Time frame: Pre-dose up to Day 56 post-dose
Time frame: Pre-dose up to Day 56 post-dose
Time frame: Pre-dose up to Day 56 post-dose
Time frame: Pre-dose up to Day 56 post-dose
Time frame: Pre-dose up to Day 28 post-dose
Time frame: Pre-dose up to Day 28 post-dose
Time frame: Up to 56 days post-dose
Time frame: Up to 56 days post-dose
Time frame: Up to 56 days post-dose
Time frame: Up to 56 days post-dose
Time frame: Baseline, Up to 56 days post-dose
Eisai Inc.
Industry
An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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