Fortrea Clinical Research Unit Inc.
Madison, Wisconsin, 53704, United States
NCT Number: NCT07308236
The primary purpose of this study is to determine the metabolism and excretion of [14C]E2086 in healthy male participants.
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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
Exclusion criteria
NOTE: All female partners of male participants will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). Examples of highly effective contraception include total abstinence, an intrauterine device, a double-barrier method (such as condom plus diaphragm with spermicide), a contraceptive implant, and oral contraceptive. Female partners of male participants who have not had a successful vasectomy, who use hormonal contraception, must be on the same hormonal contraceptive for 28 days before the male participants are dosed with trial drug, throughout the trial period and for 28 days afterwards.
E2086 oral capsule.
Time frame: Day 1 up to Day 21
Mass balance will be determined by pharmacokinetic (PK) analysis of [14C]E2086 and E2086 in the biological matrices.
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Day 1 up to Day 21
Time frame: Up to 21 days
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.
Time frame: Up to 21 days
Time frame: Up to 21 days
Time frame: Up to 21 days
Time frame: Up to 21 days
Eisai Inc.
Industry
An Open-Label, Single Dose Study to Determine the Metabolism and Excretion of [14C]E2086 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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