NCT04927793
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enanta Pharmaceuticals, Inc
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Cmax of EDP-938 in plasma
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
Single arm EDP-938
Experimental
Intervention: EDP-938 (Drug)
Outcomes
Primary Outcomes
Cmax of EDP-938 in plasma
Time Frame: Up to 11 days
AUC0-tlast of EDP-938 in plasma
Time Frame: Up to 11 days
AUC-inf in plasma
Time Frame: Up to 11 days
Amount excreted in urine (Aeu)
Time Frame: Up to 11 days
Amount excreted in feces (Aef)
Time Frame: Up to 11 days
Cmax of EDP-938 metabolites in plasma
Time Frame: Up to 11 days
Secondary Outcomes
- Safety measured by occurrence of adverse events(Up to 11 days)
Investigators
Study Sites (1)
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