NASH - Nonalcoholic Steatohepatitis
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-305 in healthy male subjects.
Interventions
DRUGEDP-305
\[14C\]EDP-305
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
* Healthy male subjects aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 32.0 kg/m2 (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, 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 that would potentially alter absorption and/or excretion of orally administered drugs (including gastrectomy and cholecystectomy; uncomplicated appendectomy and hernia repair will be allowed). * Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of EDP-305 in plasma | Up to 9 days |
| AUC of EDP-305 in plasma | Up to 9 days |
| AUC-inf in plasma | Up to 9 days |
Secondary
| Measure | Time frame |
|---|---|
| Amount excreted in urine (Aeu) | Up to 9 days |
| Amount excreted in feces (Aef) | Up to 9 days |
| Safety measured by adverse events | Up to 9 days |
Countries
United States
Outcome results
None listed