Overview

Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers

Status:
Completed
Trial end date:
2017-09-07
Target enrollment:
0
Participant gender:
All
Summary
This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of itraconazole or rifampin on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Enanta Pharmaceuticals
Treatments:
Itraconazole
Rifampin
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.

- 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.