Overview

Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers

Status:
Completed
Trial end date:
2018-08-21
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 fluconazole or quinidine 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:
Fluconazole
Quinidine
Quinidine gluconate
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.

- Clinically significant electrocardiogram abnormalities or QTcF greater than 450 ms for
males and 470 ms for females at either Screening or Day -1 (Part 2 only), or any prior
history of QT abnormality.

- For Part 2 subjects, the following cardiovascular abnormalities

- QRS duration >110 ms

- Incomplete right bundle branch block or any complete bundle branch block

- Heart rate <40 or >90 beats per minute (per vital sign capture while rested)

- History of unexplained syncope, structural heart disease, or clinically
significant arrhythmias

- Personal or family history of long QT syndrome (genetically proven or suggested
by sudden death of a close relative due to cardiac causes at a young age) or
Brugada syndrome

- PR interval >220 ms or any 2nd or 3rd degree AV block

- Ventricular pre-excitation