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

Respiratory Syncytial Virus (RSV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04927793
• Other study ID #: EDP 938-009
• Status: Completed
• Phase: Phase 1
• Start date: May 28, 2021
• Est. completion date: July 4, 2021

Study information

• Verified date: March 2022
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 4, 2021
• Est. primary completion date: July 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus (RSV)

Intervention

Drug:
• EDP-938
[14C]EDP-938

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of EDP-938 in plasma		Up to 11 days
Primary	AUC0-tlast of EDP-938 in plasma		Up to 11 days
Primary	AUC-inf in plasma		Up to 11 days
Primary	Amount excreted in urine (Aeu)		Up to 11 days
Primary	Amount excreted in feces (Aef)		Up to 11 days
Primary	Cmax of EDP-938 metabolites in plasma		Up to 11 days
Secondary	Safety measured by occurrence of adverse events		Up to 11 days