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Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers

NCT ID: NCT03213145

Last Updated: 2017-11-06

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

2017-07-11

Study Completion Date

2017-09-07

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 itraconazole or rifampin on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.

Detailed Description

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Conditions

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NASH - Nonalcoholic Steatohepatitis

Keywords

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drug-drug interaction

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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Part 1

Group Type EXPERIMENTAL

intraconazole

Intervention Type DRUG

Subjects will receive itraconazole once daily from Day 5 through Day18

EDP 305

Intervention Type DRUG

Subjects will receive EDP 305 once daily on Day 1 and Day 14

Part 2

Group Type EXPERIMENTAL

Rifampin

Intervention Type DRUG

Subjects will receive rifampin once daily from Day 5 through Day 16

EDP 305

Intervention Type DRUG

Subjects will receive EDP 305 once daily on Day 1 and Day 14

Interventions

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intraconazole

Subjects will receive itraconazole once daily from Day 5 through Day18

Intervention Type DRUG

Rifampin

Subjects will receive rifampin once daily from Day 5 through Day 16

Intervention Type DRUG

EDP 305

Subjects will receive EDP 305 once daily on Day 1 and Day 14

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

Sponsors

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Enanta Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Enanta Pharmaceuticals, Inc

Role: STUDY_DIRECTOR

Enanta Pharmaceuticals, Ind

Locations

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Pharmaceutical Research Associates, Inc.,

Lenexa, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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EDP 305-005

Identifier Type: -

Identifier Source: org_study_id