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

Sponsor
Enanta Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04927793
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
1.2
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
May 28, 2021
Actual Primary Completion Date :
Jul 4, 2021
Actual Study Completion Date :
Jul 4, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single arm EDP-938

Drug: EDP-938
[14C]EDP-938

Outcome Measures

Primary Outcome Measures

  1. Cmax of EDP-938 in plasma [Up to 11 days]

  2. AUC0-tlast of EDP-938 in plasma [Up to 11 days]

  3. AUC-inf in plasma [Up to 11 days]

  4. Amount excreted in urine (Aeu) [Up to 11 days]

  5. Amount excreted in feces (Aef) [Up to 11 days]

  6. Cmax of EDP-938 metabolites in plasma [Up to 11 days]

Secondary Outcome Measures

  1. Safety measured by occurrence of adverse events [Up to 11 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
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).

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Covance Clinical Research Unit Madison Wisconsin United States 53704

Sponsors and Collaborators

  • Enanta Pharmaceuticals

Investigators

  • Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enanta Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04927793
Other Study ID Numbers:
  • EDP 938-009
First Posted:
Jun 16, 2021
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Enanta Pharmaceuticals
AME Study

Study Results

No Results Posted as of Mar 23, 2022