This study is being conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of \[14C\]-EP262 in healthy male participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Single dose of \[14C\]-EP262 administered orally.
Pharmaron Clinical Pharmacology Center (CPC)
Baltimore, Maryland, United States
Mass balance of [14C]-EP262
Assessed by the total recovery of radioactivity from urine and feces
Time frame: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Pharmacokinetics (PK) of EP262 and [14C]
Assessed by the concentration of EP262 in plasma and \[14C\] in whole blood, plasma, urine, and feces
Time frame: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Metabolite profile of EP262
Assessed by the concentration of EP262 metabolites in plasma, urine, and feces
Time frame: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Safety and tolerability of [14C]-EP262
Assessed by the incidence of treatment emergent adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiogram, and physical examination findings
Time frame: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
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