NASH - Nonalcoholic Steatohepatitis
Conditions
Keywords
drug-drug interaction
Brief 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.
Interventions
DRUGFluconazole
Subjects will receive fluconazole once daily from Day 5 to Day 18
DRUGQuinidine
Subjects will receive quinidine twice daily from Day 5 to Day 12
DRUGEDP-305
Subjects will receive a single dose of EDP-305 on Day 1 and Day 14
Sponsors
Enanta Pharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
2-Part Single Group study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of EDP-305 with and without coadministration with fluconazole | Up to 19 days |
| AUC of EDP-305 with and without coadministration with fluconazole | Up to 19 days |
| Cmax of EDP-305 with and without coadministration with quinidine | Up to 13 days |
| AUC of EDP-305 with and without coadministration with quinidine | Up to 13 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety measured by adverse events | Up to 25 days |
Countries
United States
Outcome results
None listed