Respiratory Syncytial Virus (RSV)
Conditions
Keywords
AME Study
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.
Interventions
DRUGEDP-938
\[14C\]EDP-938
Sponsors
Enanta Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC-inf in plasma | Up to 11 days |
| Cmax of EDP-938 in plasma | Up to 11 days |
| AUC0-tlast of EDP-938 in plasma | Up to 11 days |
| Cmax of EDP-938 metabolites in plasma | Up to 11 days |
| Amount excreted in urine (Aeu) | Up to 11 days |
| Amount excreted in feces (Aef) | Up to 11 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety measured by occurrence of adverse events | Up to 11 days |
Countries
United States
Outcome results
None listed