Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in 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.
• 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