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A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323.

NCT06847464 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-07-01

No results posted yet for this study

Summary

The primary aim of the study is to assess the effect of itraconazole, carbamazepine, quinidine, and fluconazole individually on the pharmacokinetics and safety of EDP-323 in healthy adult participants. Each participant's duration in the study will be dependent upon which study part they are enrolled.

Conditions

  • RSV Infection
  • Drug Drug Interaction (DDI)

Interventions

DRUG

EDP-323

Subjects will receive EDP-323 on Days 1 and 14

DRUG

Itraconazole

Subjects will receive itraconazole QD Days 5-18

DRUG

EDP-323

Subjects will receive EDP-323 on Days 1 and 23

DRUG

carbamazepine

Subjects will receive carbamazepine on Days 5 - 27

DRUG

EDP-323

Subjects will receive EDP-323 on Days 1 and 8

DRUG

Quinidine

Subjects will receive quinidine on Days 5-12

DRUG

EDP-323

Subjects will receive EDP-323 on Days 1 and 14

DRUG

fluconazole

Subjects will receive fluconazole on Days 5-18

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
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2025-05-24
Completion
2025-06-01
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 NCT06847464 on ClinicalTrials.gov