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

Launched by ESCIENT PHARMACEUTICALS, INC · Oct 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called [14C]-EP262 to understand how it is absorbed, processed, and eliminated by the body after a single dose taken by mouth. The researchers are specifically looking at healthy male participants to gather important information about how the body reacts to this medication.

To be eligible for the study, participants need to be healthy males between the ages of 18 and 55, with a normal weight and no serious health conditions. Participants will undergo screening to ensure they do not have certain infections and must follow specific guidelines, like avoiding tobacco products. Those who join the study can expect to take one dose of the medication and then be monitored for how it moves through their body. This trial is currently recruiting, so if you meet the criteria and are interested, it could be a chance to contribute to important research.

Gender

MALE

Eligibility criteria

• 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