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A Study of EDP 305 in Healthy Subjects and Subjects With Presumptive NAFLD

NCT02918929 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2017-08-21

No results posted yet for this study

Summary

This randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-305 in healthy adult subjects, and adult subjects with presumptive NAFLD (i.e., obese subjects with or without prediabetes or T2DM).

Conditions

  • Presumptive NAFLD

Interventions

DRUG

EDP 305

DRUG

Placebo

placebo to match EDP 305

Sponsors & Collaborators

  • Pharmaceutical Research Associates

    collaborator OTHER

  • Enanta Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Daniel Dickerson, MD · Pharmaceutical Research Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02918929 on ClinicalTrials.gov