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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-19

Study Completion Date

2018-08-21

Brief Summary

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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.

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Detailed Description

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Conditions

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NASH - Nonalcoholic Steatohepatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

2-Part Single Group study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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EDP-305 and fluconazole interaction (Part 1)

Group Type EXPERIMENTAL

Fluconazole

Intervention Type DRUG

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

EDP-305

Intervention Type DRUG

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

EDP-305 and quinidine interaction (Part 2)

Group Type EXPERIMENTAL

Quinidine

Intervention Type DRUG

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

EDP-305

Intervention Type DRUG

Subjects will receive a single dose of EDP-305 on Day 1 and Day 8

Interventions

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Fluconazole

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

Intervention Type DRUG

Quinidine

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

Intervention Type DRUG

EDP-305

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

Intervention Type DRUG

EDP-305

Subjects will receive a single dose of EDP-305 on Day 1 and Day 8

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* PR interval \>220 ms or any 2nd or 3rd degree AV block
* Ventricular pre-excitation

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes