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

Escient Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: EP262

Study type: Interventional

Funder types: Industry

Identifiers

NCT06645704

EP-262-104

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

[14C]-EP262 25 mg

Experimental group

Description:

Administered orally.

Treatment:

Drug: EP262