An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral Administration

An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral Administration

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.

Inclusion Criteria:

• Males aged 18 to 55 years
• Body mass index of 18 to 32 kg/m2 and body weight of 55 to 100 kg
• Negative result for HIV, HBV, and HCV at Screening
• Male subjects with female partners of reproductive potential must be surgically sterile or use adequate birth control
• No use of tobacco or nicotine containing products within the past 6 months

Exclusion Criteria:

• History or presence of any condition or prior surgery that could pose a significant risk in the opinion of the investigator
• History of malignancy within the past 5 years
• History of any serious allergic reactions or hypersensitivity
• Recent history of incomplete bladder emptying with voiding or awakening more than once at a night to void
• Usual habit of bowel movements of less than 1 or more than 3 bowel movements per day