Absorption, Metabolism, and Excretion (AME) Study of [14C]EDP-938 in Healthy Male Subjects
- Registration Number
- NCT04927793
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
- 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
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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).
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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.
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Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm EDP-938 EDP-938 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Safety measured by occurrence of adverse events Up to 11 days
Trial Locations
- Locations (1)
Covance Clinical Research Unit
🇺🇸Madison, Wisconsin, United States