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

Enanta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Drug: Fluconazole; Drug: EDP-305; Drug: Quinidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03610945

EDP 305-007

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

EDP-305 and fluconazole interaction (Part 1)

Experimental group

Treatment:

Drug: EDP-305

Drug: EDP-305

Drug: Fluconazole

EDP-305 and quinidine interaction (Part 2)

Experimental group

Treatment:

Drug: Quinidine

Drug: EDP-305

Drug: EDP-305