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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06645704

Enrollment

Registered

2024-10-17

Start date

2024-10-01

Completion date

2024-12-10

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Brief summary

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.

Interventions

DRUGEP262

Single dose of \[14C\]-EP262 administered orally.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Mass balance of [14C]-EP262	Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)	Assessed by the total recovery of radioactivity from urine and feces
Pharmacokinetics (PK) of EP262 and [14C]	Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)	Assessed by the concentration of EP262 in plasma and \[14C\] in whole blood, plasma, urine, and feces

Secondary

Measure	Time frame	Description
Metabolite profile of EP262	Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)	Assessed by the concentration of EP262 metabolites in plasma, urine, and feces
Safety and tolerability of [14C]-EP262	Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)	Assessed by the incidence of treatment emergent adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiogram, and physical examination findings

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026