Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers

NCT03610945 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 305-007
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

drug-drug interaction

Outcome Measures

Primary Outcomes (4)

• Cmax of EDP-305 with and without coadministration with fluconazole

  Up to 19 days

• AUC of EDP-305 with and without coadministration with fluconazole

  Up to 19 days

• Cmax of EDP-305 with and without coadministration with quinidine

  Up to 13 days

• AUC of EDP-305 with and without coadministration with quinidine

  Up to 13 days

Secondary Outcomes (1)

• Safety measured by adverse events

  Up to 25 days

Study Arms (2)

EDP-305 and fluconazole interaction (Part 1)

EXPERIMENTAL

Drug: Fluconazole; Drug: EDP-305

EDP-305 and quinidine interaction (Part 2)

EXPERIMENTAL

Drug: Quinidine; Drug: EDP-305

Interventions

Fluconazole DRUG

Subjects will receive fluconazole once daily from Day 5 to Day 18

EDP-305 and fluconazole interaction (Part 1)

Quinidine DRUG

Subjects will receive quinidine twice daily from Day 5 to Day 12

EDP-305 and quinidine interaction (Part 2)

EDP-305 DRUG

Subjects will receive a single dose of EDP-305 on Day 1 and Day 14

EDP-305 and fluconazole interaction (Part 1)

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.

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 the first dose of study drug.
• Clinically significant electrocardiogram abnormalities or QTcF greater than 450 ms for males and 470 ms for females at either Screening or Day -1 (Part 2 only), or any prior history of QT abnormality.
• For Part 2 subjects, the following cardiovascular abnormalities
• QRS duration \>110 ms
• Incomplete right bundle branch block or any complete bundle branch block
• Heart rate \<40 or \>90 beats per minute (per vital sign capture while rested)
• History of unexplained syncope, structural heart disease, or clinically significant arrhythmias
• Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

Pharmaceutical Research Associates, Inc.,

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Fluconazole; Quinidine; EDP-305

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cinchona Alkaloids; Alkaloids; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2-Part Single Group study

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 1, 2018
• Study Start: July 19, 2018
• Primary Completion: August 15, 2018
• Study Completion: August 21, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)