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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: EP262

• Registration Number: NCT06645704
• Lead Sponsor: Escient Pharmaceuticals, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-01
• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-15
• Study First Posted: 2024-10-17
• Primary Completion: 2024-12-10
• Study Completion: 2024-12-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]-EP262 25 mg	EP262	Administered orally.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pharmaron Clinical Pharmacology Center (CPC); 🇺🇸 Baltimore, Maryland, United States