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CompletedNCT06645704Updated Feb 24, 2025

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

A Phase 1 interventional study of EP262 in Healthy Participants, sponsored by Escient Pharmaceuticals, Inc. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by Escient Pharmaceuticals, Inc · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2024, 1 year 9 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

Escient Pharmaceuticals, Inc is the lead sponsor of 6 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    [14C]-EP262 25 mg

    Administered orally.

    Drug: EP262

Interventions

  • DrugEP262

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

06

What researchers measure

Primary outcomes

  1. Mass balance of [14C]-EP262

    Assessed by the total recovery of radioactivity from urine and feces

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

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

    Assessed by the concentration of EP262 in plasma and \[14C\] in whole blood, plasma, urine, and feces

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

Secondary outcomes

  1. Metabolite profile of EP262

    Assessed by the concentration of EP262 metabolites in plasma, urine, and feces

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

  2. 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

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

07

Study locations

1 site
  • Pharmaron Clinical Pharmacology Center (CPC)
    Baltimore, Maryland 21201, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06645704
Lead sponsor
Escient Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Oct 17, 2024
Start date
Oct 1, 2024
Primary completion
Dec 10, 2024
Completion
Dec 10, 2024
Last update
Feb 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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