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

A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics and Safety of EDP-305 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03213145

Enrollment

Registered

2017-07-11

Start date

2017-07-11

Completion date

2017-09-07

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

drug-drug interaction

Brief summary

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.

Interventions

DRUGintraconazole

Subjects will receive itraconazole once daily from Day 5 through Day18

DRUGRifampin

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

DRUGEDP 305

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

2-Part Single Group study.

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Cmax of EDP-305 with and without coadministration with itraconazole	Up to 19 days
AUC of EDP-305 with and without coadministration with itraconazole	Up to 19 days
Cmax of EDP-305 with and without coadministration with rifampin	Up to 17 days
AUC of EDP-305 with and without coadministration with rifampin	Up to 17 days

Secondary

Measure	Time frame
Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).	Up to 19 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026