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

NCT03213145 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-11-06

No results posted yet for this study

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.

Conditions

  • NASH - Nonalcoholic Steatohepatitis

Interventions

DRUG

intraconazole

Subjects will receive itraconazole once daily from Day 5 through Day18

DRUG

Rifampin

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

DRUG

EDP 305

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

Sponsors & Collaborators

  • Enanta Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Enanta Pharmaceuticals, Inc · Enanta Pharmaceuticals, Ind

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2017-08-10
Completion
2017-09-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03213145 on ClinicalTrials.gov