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

NCT06645704 | Completed Phase 1 FDA Drug

• 1 other identifier: EP-262-104
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Metabolite profile of EP262

  Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)

• Safety and tolerability of [14C]-EP262

  Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)

Study Arms (1)

[14C]-EP262 25 mg

EXPERIMENTAL

Administered orally.

Drug: EP262

Interventions

EP262 DRUG

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

[14C]-EP262 25 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Escient Pharmaceuticals, Inc: lead

Study Sites (1)

Pharmaron Clinical Pharmacology Center (CPC)

Baltimore, Maryland, 21201, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: October 1, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)