EDP-494-001: A Study of EDP-494 in Healthy Subjects and Hepatitis C Patients

NCT02652377 | Completed Phase 1

• 1 other identifier: EDP-494-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind study will assess the safety, pharmacokinetics and efficacy of a single and multiple dose(s) of orally QD administered EDP-494 in healthy volunteers (HV) and in treatment-naive subjects with GT1/3 chronic hepatitis C (CHC) infection.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Composite number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, and abnormal clinical laboratory results administered to healthy volunteers and multiple doses of EDP-494

  Tabulation of the number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results (including chemistry, hematology, and urine). Administered to healthy volunteers and multiple doses of EDP-494 administered to healthy volunteers and subjects with Chronic Hepatitis C (CHC) genotype 1 and 3 infection

  From screening and baseline to the 4 week follow-up visit

Secondary Outcomes (6)

• Cmax

  0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72 (Day 4), 96 (Day 5), 120 (Day 6)*, 144 (Day 7) and 168 (Day 8) hrs postdose

• Cmax

  Day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 5, 7, 9, 12: 0 (Predose); Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72, 96, 120, 144 and 168 hrs postdose

• AUC

  0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72, 96, 120*, 144, and 168 hrs postdose

• AUC

  Day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 5, 7, 9, 12: 0 (Predose);Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72, 96, 120, 144 and 168 hrs postdose

• Change from baseline in plasma HCV RNA (log10 IU/mL)

  Baseline up to 14 days

Study Arms (4)

EDP-494 SAD Cohorts

EXPERIMENTAL

EDP-494, oral 50 mg, 100mg, 200mg, 400mg and 800 mg, capsules, once daily in one single administration

Drug: EDP-494

EDP-494 MAD/POC Cohorts

EXPERIMENTAL

EDP-494, oral 200mg, 400mg and 800 mg, capsules, once daily for 14 days

Drug: EDP-494

EDP-494 SAD Placebo Cohort

PLACEBO COMPARATOR

Drug: Placebo

EDP-494 MAD/POC Placebo Cohort

PLACEBO COMPARATOR

Drug: Placebo

Interventions

EDP-494 DRUG

10, 100 and 200 mg capsules

EDP-494 MAD/POC Cohorts; EDP-494 SAD Cohorts

Placebo DRUG

placebo to match EDP-494

EDP-494 MAD/POC Placebo Cohort; EDP-494 SAD Placebo Cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Body mass index of 18 to 30 kg/m2 with a minimum body weight of 50 kg.
• An informed consent document signed and dated by the subject.

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.
• Any condition possibly affecting drug absorption (e.g., gastrectomy).
• 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, herbal supplements, hormonal therapy/replacement or CYP3A4 substrates, inducers and inhibitors within 14 days prior to the first dose of study medication
• Males and females aged 18 years and less than 70 years.
• 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.
• Body mass index of 18 to 36 kg/m2 with a minimum body weight of 50 kg.
• Treatment naïve subjects with chronic HCV infection,
• HCV GT1 (including 1a, 1b, or mixed subtypes of GT1) or GT3.
• HCV RNA ≥100,000 IU/mL at screening.

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

Auckland Clinical Studies Ltd

Auckland, 1150, New Zealand

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Edward Gane, MD

  Auckland Clinical Studies (ACS),

  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: January 6, 2016
• First Posted: January 11, 2016
• Study Start: January 10, 2016
• Primary Completion: December 27, 2016
• Study Completion: December 27, 2016
• Last Updated: January 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)