Back to resultsAbsorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
Primary Purpose
NASH - Nonalcoholic Steatohepatitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EDP-305
Sponsored by
About this trial
This is an interventional basic science trial for NASH - Nonalcoholic Steatohepatitis focused on measuring AME Study
Eligibility Criteria
Inclusion Criteria:
- Healthy male subjects aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 32.0 kg/m2 (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, 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 that would potentially alter absorption and/or excretion of orally administered drugs (including gastrectomy and cholecystectomy; uncomplicated appendectomy and hernia repair will be allowed).
- Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
Sites / Locations
- Covance Clinical Research Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm EDP-305
Arm Description
Outcomes
Primary Outcome Measures
Cmax of EDP-305 in plasma
AUC of EDP-305 in plasma
AUC-inf in plasma
Secondary Outcome Measures
Amount excreted in urine (Aeu)
Amount excreted in feces (Aef)
Safety measured by adverse events
Full Information
NCT ID
NCT03748628
First Posted
October 31, 2018
Last Updated
November 18, 2018
Sponsor
Enanta Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT03748628
Brief Title
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
Official Title
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]EDP-305 Following a Single Oral Dose in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 5, 2018 (Actual)
Primary Completion Date
October 13, 2018 (Actual)
Study Completion Date
October 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enanta Pharmaceuticals, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]EDP-305 in healthy male subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis
Keywords
AME Study
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm EDP-305
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
EDP-305
Intervention Description
[14C]EDP-305
Primary Outcome Measure Information:
Title
Cmax of EDP-305 in plasma
Time Frame
Up to 9 days
Title
AUC of EDP-305 in plasma
Time Frame
Up to 9 days
Title
AUC-inf in plasma
Time Frame
Up to 9 days
Secondary Outcome Measure Information:
Title
Amount excreted in urine (Aeu)
Time Frame
Up to 9 days
Title
Amount excreted in feces (Aef)
Time Frame
Up to 9 days
Title
Safety measured by adverse events
Time Frame
Up to 9 days
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male subjects aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 32.0 kg/m2 (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, 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 that would potentially alter absorption and/or excretion of orally administered drugs (including gastrectomy and cholecystectomy; uncomplicated appendectomy and hernia repair will be allowed).
Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enanta Pharmaceuticals, Inc
Organizational Affiliation
Enanta Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Covance Clinical Research Unit
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
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