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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: EP262

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Pharmaron Clinical Pharmacology Center (CPC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-EP262 25 mg; Administered orally.	Drug: EP262; Single dose of [14C]-EP262 administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mass balance of [14C]-EP262	Assessed by the total recovery of radioactivity from urine and feces	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	Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolite profile of EP262	Assessed by the concentration of EP262 metabolites in plasma, urine, and feces	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	Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)

Collaborators and Investigators

• Sponsor: Escient Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): December 10, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: EP-262-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No