Overview
Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers
Status:
Completed
Completed
Trial end date:
2017-09-07
2017-09-07
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Enanta PharmaceuticalsTreatments:
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.