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

NCT06917508 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 323-006
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Drug Drug Interaction

Outcome Measures

Primary Outcomes (2)

• Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323

  Up to 17 Days

• AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323

  Up to 17 Days

Secondary Outcomes (1)

• Safety measured by adverse events

  Up to 22 days

Study Arms (1)

EDP-323, midazolam, caffeine and rosuvastatin

EXPERIMENTAL

Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days

Drug: EDP-323; Drug: Midazolam; Drug: Caffeine; Drug: Rosuvastatin

Interventions

EDP-323 DRUG

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

EDP-323, midazolam, caffeine and rosuvastatin

Midazolam DRUG

Subjects will receive midazolam once daily on Days 1 and 12

EDP-323, midazolam, caffeine and rosuvastatin

Caffeine DRUG

Subjects will receive caffeine once daily on Days 1 and 12

EDP-323, midazolam, caffeine and rosuvastatin

Rosuvastatin DRUG

Subjects will receive rosuvastatin once daily on Days 2 and 13

EDP-323, midazolam, caffeine and rosuvastatin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An informed consent document signed and dated by the subject
• Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive
• Screening body weight \>50 kg and body mass index (BMI) of 18 to 32 kg/m2
• Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of EDP-323. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

You may not qualify if:

• Clinically relevant evidence or history of illness or disease
• Pregnant or nursing females
• History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection
• Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
• Positive for HIV or hepatitis
• Positive urine drug screen
• Current tobacco smokers or use of tobacco within 3 months prior to Screening.
• Received any vaccine, an investigational agent, or biological product within 28 days or 5 times the t½ of receipt of study drug, whichever is longer.
• Drug sensitivity to midazolam, caffeine, rosuvastatin

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

ICON, plc

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Midazolam; Caffeine; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Xanthines; Alkaloids; Purinones; Purines; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: March 13, 2025
• Primary Completion: June 6, 2025
• Study Completion: June 13, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)