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

NCT ID: NCT04927793

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-28
• Study Completion Date: 2021-07-04

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single arm EDP-938

Group Type: EXPERIMENTAL

EDP-938

Intervention Type: DRUG

\[14C\]EDP-938

Interventions

EDP-938

\[14C\]EDP-938

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Enanta Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enanta Pharmaceuticals, Inc

Role: STUDY_DIRECTOR

Enanta Pharmaceuticals, Inc

Locations

Covance Clinical Research Unit

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

EDP 938-009

Identifier Type: -

Identifier Source: org_study_id