Absorption, Metabolism, and Excretion (AME) Study of [14C]EDP-938 in Healthy Male Subjects

Study Overview
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Brief Summary
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A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]EDP-938 in healthy male subjects.

Official Title
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A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]EDP-938 Following a Single Oral Dose in Healthy Male Subjects

Conditions
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Respiratory Syncytial Virus (RSV)

Intervention / Treatment
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* Drug: EDP-938


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males of any ethnic origin, between 18 and 55 years of age, inclusive. Able to comprehend and willing to sign an Informed Consent Form In good health, determined by no clinically significant findings from medical history, physical examination (check-in only), 12-lead ECG, vital signs measurements, and clinical laboratory evaluations Exclusion Criteria: Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). History of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). a. Subjects with a history of cholecystitis, cholelithiasis, and/or choledocholithiasis will also be excluded. Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening. A body surface area-adjusted estimated glomerular filtration rate (eGFR) ≤ 90 mL/min per 1.73 m2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, at screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm EDP-938<br> | Drug: EDP-938<br>* [14C]EDP-938<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of EDP-938 in plasma |  | Up to 11 days | 
| AUC0-tlast of EDP-938 in plasma |  | Up to 11 days | 
| AUC-inf in plasma |  | Up to 11 days | 
| Amount excreted in urine (Aeu) |  | Up to 11 days | 
| Amount excreted in feces (Aef) |  | Up to 11 days | 
| Cmax of EDP-938 metabolites in plasma |  | Up to 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by occurrence of adverse events |  | Up to 11 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AME Study