Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-05

Study Completion Date

2018-10-13

Brief Summary

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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.

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Detailed Description

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Conditions

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NASH - Nonalcoholic Steatohepatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Single arm EDP-305

Group Type EXPERIMENTAL

EDP-305

Intervention Type DRUG

\[14C\]EDP-305

Interventions

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EDP-305

\[14C\]EDP-305

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes