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

Completed · Phase 1 · Has a placebo group

Conditions studied: Presumptive NAFLD

In brief

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).

Key facts

Study ID

NCT02918929

Run by

Enanta Pharmaceuticals, Inc

People needed

146

Starts

2016-09-01

Expected to finish

2017-06-01

Last updated by the study team

2017-08-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Clinically relevant evidence or history of illness or disease.
• Pregnant or nursing females.
• History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
• A positive urine drug screen at screening or Day -1.
• Current tobacco smokers or use of tobacco within 3 months prior to screening.
• Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
• History of regular alcohol consumption
• Participation in a clinical trial within 30 days prior to study drug administration.
• Use of prescription drugs, non-prescription drugs, dietary supplements including Vitamin E herbal supplements, hormonal therapy/replacement or CYP3A4 substrates, inducers and inhibitors within 14 days prior to the first dose of study medication.
• Additional Exclusion Criteria for MAD Subjects with Presumptive NAFLD:
• Subjects taking any antidiabetic medication.
• Subjects with unstable proliferative retinopathy, macular oedema (fundus examination performed in the previous year will be considered relevant on Investigator's judgement).
• Subject has taken fibrates, statins, and/or Vitamin E within 6 weeks prior to the first dose administration.
• Subjects with a history of bariatric surgery and any other gastrointestinal surgery relative to weight loss.
• Subjects with common causes of secondary hepatic steatosis.

Where it is running

• Pharmaceutical Research Associates, Inc., — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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