Absorption, Metabolism, and Excretion (AME) Study of [14C]EDP-938 in Healthy Male Subjects

NCT04927793 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 938-009
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

AME Study

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Safety measured by occurrence of adverse events

  Up to 11 days

Study Arms (1)

Single arm EDP-938

EXPERIMENTAL

Drug: EDP-938

Interventions

EDP-938 DRUG

\[14C\]EDP-938

Single arm EDP-938

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

EDP-938

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: May 28, 2021
• Primary Completion: July 4, 2021
• Study Completion: July 4, 2021
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)