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OpenTrials
Completed

NCT Number: NCT06645704

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron Clinical Pharmacology Center (CPC)

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EP262

Drug

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

Primary outcomes

  1. Mass balance of [14C]-EP262

    Time frame: 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

  2. Pharmacokinetics (PK) of EP262 and [14C]

    Time frame: 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 outcomes

  1. Metabolite profile of EP262

    Time frame: 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

  2. Safety and tolerability of [14C]-EP262

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Escient Pharmaceuticals, Inc

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2024
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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