Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers.

Enanta Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

NASH

Treatments

Drug: EDP-305

Drug: Rosuvastatin

Drug: Midazolam

Drug: Caffeine

Study type

Interventional

Funder types

Industry

Identifiers

NCT03187496

EDP 305-004

Details and patient eligibility

About

A non-randomized, multiple-dose, open-label, single sequence study to evaluate effect of concomitant administration of EDP-305 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy human volunteers.

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.
Female subjects must be of non-childbearing potential.

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.