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