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

NCT03610945 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-12-05

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 fluconazole or quinidine on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.

Conditions

  • NASH - Nonalcoholic Steatohepatitis

Interventions

DRUG

Fluconazole

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

DRUG

Quinidine

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

DRUG

EDP-305

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

DRUG

EDP-305

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

Sponsors & Collaborators

  • Enanta Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Enanta Pharmaceuticals, Inc · Enanta Pharmaceuticals, Inc

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
2018-07-19
Primary Completion
2018-08-15
Completion
2018-08-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03610945 on ClinicalTrials.gov