MedTrace Logo

Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects

NCT04783753 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-08-16

No results posted yet for this study

Summary

Non-randomized, 3-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of itraconazole, carbamazepine, or quinidine on the PK and safety of EDP-514 in healthy adult subjects.

Conditions

Interventions

DRUG

EDP-514

Subjects will receive EDP-514 on Days 1 and 14

DRUG

EDP-514

Subjects will receive EDP-514 on Days 1 and 23

DRUG

EDP-514

Subjects will receive EDP-514 on Days 1 and 8

DRUG

Itraconazole

Subjects will receive itraconazole QD for 14 days

DRUG

Carbamazepin

Subjects will receive carbamazepine BID for 23 days

DRUG

Quinidine

Subjects will receive quinidine BID for 8 days

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • 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
2020-11-05
Primary Completion
2021-06-28
Completion
2021-07-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04783753 on ClinicalTrials.gov