Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin 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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-11

Study Completion Date

2017-06-14

Brief Summary

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A non-randomized, multiple-dose, open-label, single sequence study to evaluate effect of concomitant administration of EDP-305 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy human volunteers.

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Detailed Description

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Conditions

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NASH

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Each subject will receive midazolam on Days 1 and 12.

Caffeine

Intervention Type DRUG

Each subject will receive caffeine on Days 1 and 12.

Rosuvastatin

Intervention Type DRUG

Each subject will receive rosuvastatin on Days 2 and 13.

EDP-305

Intervention Type DRUG

Each subject will receive EDP-305 on Days 5 through 15.

Interventions

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Midazolam

Each subject will receive midazolam on Days 1 and 12.

Intervention Type DRUG

Caffeine

Each subject will receive caffeine on Days 1 and 12.

Intervention Type DRUG

Rosuvastatin

Each subject will receive rosuvastatin on Days 2 and 13.

Intervention Type DRUG

EDP-305

Each subject will receive EDP-305 on Days 5 through 15.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes