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

Enanta Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

RSV Infection

Drug Drug Interaction

Treatments

Drug: Caffeine

Drug: Midazolam

Drug: Rosuvastatin

Drug: EDP-323

Study type

Interventional

Funder types

Industry

Identifiers

NCT06917508

EDP 323-006

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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