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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2024-12-10

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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[14C]-EP262 25 mg

Administered orally.

Group Type EXPERIMENTAL

EP262

Intervention Type DRUG

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

Interventions

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EP262

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes