NCT03748628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2018

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
Last Updated

November 21, 2018

Status Verified

October 1, 2018

Enrollment Period

8 days

First QC Date

October 31, 2018

Last Update Submit

November 18, 2018

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

AME Study

Outcome Measures

Primary Outcomes (3)

  • Cmax of EDP-305 in plasma

    Up to 9 days

  • AUC of EDP-305 in plasma

    Up to 9 days

  • AUC-inf in plasma

    Up to 9 days

Secondary Outcomes (3)

  • Amount excreted in urine (Aeu)

    Up to 9 days

  • Amount excreted in feces (Aef)

    Up to 9 days

  • Safety measured by adverse events

    Up to 9 days

Study Arms (1)

Single arm EDP-305

EXPERIMENTAL
Drug: EDP-305

Interventions

EDP-305DRUG

\[14C\]EDP-305

Single arm EDP-305

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

EDP-305

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

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

October 31, 2018

First Posted

November 21, 2018

Study Start

October 5, 2018

Primary Completion

October 13, 2018

Study Completion

October 13, 2018

Last Updated

November 21, 2018

Record last verified: 2018-10

Locations

US(1)