Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects

Enanta Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

COVID-19

Treatments

Drug: EDP-235

Drug: Midazolam

Drug: Rosuvastatin

Drug: Caffeine

Study type

Interventional

Funder types

Industry

Identifiers

EDP 235-003

Details and patient eligibility

About

A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin.

Enrollment

24 patients

Sex

All

Ages

18 to 55 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 55 years, inclusive
Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-235. 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
A positive urine drug screen at Screening or Day -1
Current tobacco smokers or use of tobacco within 3 months prior to Screening.
Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
History of regular alcohol consumption
Participation in a clinical trial within 30 days prior to the first dose of study drug
History of drug allergy to midazolam, caffeine, or rosuvastatin