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

NCT02918929 | Completed Phase 1

• 1 other identifier: EDP 305-001
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

First-in-human; Single Ascending Dose; Multiple Ascending Dose

Outcome Measures

Primary Outcomes (1)

• Safety data including but not limited to adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urinalysis).

  From screening to the 7-day post treatment safety follow up visit.

Secondary Outcomes (4)

• Cmax

  0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72 (D4), and 96 (D5) hrs post dose.

• Cmax

  Day 1: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 4, 5, 7, 9, 12; Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24 (D15), 30, 36, 48 (D16), 60, 72 (D17), and 96 (D18) hrs postdose

• AUC

  0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72 (D4), and 96 (D5) hrs post dose.

• AUC

  Day 1: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 4, 5, 7, 9, 12; Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24 (D15), 30, 36, 48 (D16), 60, 72 (D17), and 96 (D18) hrs postdose

Other Outcomes (6)

• Change from baseline: FGF19

  Day 1 predose and postdose hours 2, 4, 8, 12, and 24 (i.e., Day 2 predose)

• Change from baseline: C4

  Day 1 predose and postdose hours 2, 4, 8, 12, and 24 (i.e., Day 2 predose)

• Change from baseline: FGF19

  Day 1 predose and postdose hours 2, 4, 6, 8, 12 and 24 (i.e., Day 2 predose); Day 7 predose and postdose hours 8, 12, and 24 (i.e., Day 8 predose); Day 14 predose and postdose hours 8, 12, and 24 (i.e., Day 15 predose)

Study Arms (4)

EDP 305 SAD Cohorts

EXPERIMENTAL

EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration

Drug: EDP 305

EDP 305 MAD Cohorts

EXPERIMENTAL

EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral suspension, once daily for 14 days

Drug: EDP 305

EDP 305 SAD Placebo Cohort

PLACEBO COMPARATOR

Matching placebo, oral suspension, once daily in one single administration

Drug: Placebo

EDP 305 MAD Placebo Cohort

PLACEBO COMPARATOR

Matching placebo, oral suspension, once daily for 14 days

Drug: Placebo

Interventions

EDP 305 DRUG

EDP 305 MAD Cohorts; EDP 305 SAD Cohorts

Placebo DRUG

placebo to match EDP 305

EDP 305 MAD Placebo Cohort; EDP 305 SAD Placebo Cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• An informed consent document signed and dated by the subject.
• Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
• Female subjects must be of non-childbearing potential.
• All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug.
• For healthy volunteers only (see below for Subjects with presumptive NAFLD): Body mass index of 18 to 30 kg/m2 with a minimum body weight of 50 kg.
• Body mass index of \>28 and \<35 kg/m2 at screening.
• WITH or WITHOUT one of the following:
• Type 2 diabetes mellitus diagnosed by one of the following methods:
• As defined by the American Diabetes Association (ADA), as one of the following criteria: a) symptoms of diabetes plus casual plasma glucose concentration \>200 mg/dL (11.1 mmol/L) OR b) Fasting plasma glucose \>126 mg/dL (7.0 mmol/L) OR c) 2-hour post-load glucose \>200 mg/dL (11.1 mmol/L) during a 75 g oGTT.
• HbA1c of at least 6.5%. --- OR---
• Prediabetes diagnosed as defined by the ADA as a) an HbA1c of 5.7% - 6.4% OR b) fasting blood glucose of 100-125 mg/dL OR c) an oGTT 2-hour blood glucose of 140 mg/dL - 199 mg/dL.

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.
• 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.

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead
• Pharmaceutical Research Associates: collaborator

Study Sites (1)

Pharmaceutical Research Associates, Inc.,

Lenexa, Kansas, 66219, United States

Location

Study Officials

• Daniel Dickerson, MD

  Pharmaceutical Research Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 29, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 21, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)