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A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants

NCT06917508 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-07-01

No results posted yet for this study

Summary

The primary aim of this study is to assess the effect of EDP-323 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy adult participants.

Conditions

  • RSV Infection
  • Drug Drug Interaction

Interventions

DRUG

Caffeine

Subjects will receive caffeine once daily on Days 1 and 12

DRUG

Rosuvastatin

Subjects will receive rosuvastatin once daily on Days 2 and 13

DRUG

EDP-323

Subjects will receive EDP-323 once daily on Days 5-15

DRUG

Midazolam

Subjects will receive midazolam once daily on Days 1 and 12

Sponsors & Collaborators

  • Enanta Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Enanta Pharmaceuticals, Inc · Enanta Pharmaceuticals, Inc

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-03-13
Primary Completion
2025-06-06
Completion
2025-06-13
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 NCT06917508 on ClinicalTrials.gov