Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
- Registration Number
- NCT03748628
- 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-305 in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm EDP-305 EDP-305 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Covance Clinical Research Unit
🇺🇸Madison, Wisconsin, United States