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

COMPLETEDPHASE1

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

A Non-Randomized, Multiple-Dose, Open-Label, Single Sequence Study to Evaluate the Effect of Concomitant Administration of EDP-323 on the Pharmacokinetics and Safety of Midazolam, Caffeine, and Rosuvastatin in Healthy Participants

NCT06917508•Enanta Pharmaceuticals, Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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

Locations (1)

ICON, plc

San Antonio, Texas, United States

Key Dates

Start Date

March 13, 2025

Primary Completion Date

June 6, 2025

Completion Date

June 13, 2025

Last Updated

July 1, 2025

Enrollment

ACTUAL participants

Conditions

RSV InfectionDrug Drug Interaction

Interventions

EDP-323

DRUG

Midazolam

DRUG

Caffeine

DRUG

Rosuvastatin

DRUG

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

NCT03596801

RSV Infection

View study

COMPLETEDPHASE1

Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

NCT06583031

RSV InfectionhMPV

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age

Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.

Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit