Drug-Drug Interaction Study Between Fluconazole and EDP-938 in Healthy Subjects

Enanta Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

RSV Infection

Treatments

Drug: Fluconazole

Drug: EDP-938

Study type

Interventional

Funder types

Industry

Identifiers

NCT04871724

EDP 938-007

Details and patient eligibility

About

A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 938.

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.
Clinically significant history of drug sensitivity or allergy to fluconazole or other azole antifungals