Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Interventions
- Registration Number
- NCT03610945
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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.
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Clinically relevant evidence or history of illness or disease.
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Pregnant or nursing females.
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History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
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A positive urine drug screen at screening or Day -1.
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Current tobacco smokers or use of tobacco within 3 months prior to screening.
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Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
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History of regular alcohol consumption.
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Participation in a clinical trial within 30 days prior to the first dose of study drug.
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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.
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EDP-305 and fluconazole interaction (Part 1) Fluconazole - EDP-305 and quinidine interaction (Part 2) EDP-305 - EDP-305 and fluconazole interaction (Part 1) EDP-305 - EDP-305 and quinidine interaction (Part 2) Quinidine -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Safety measured by adverse events Up to 25 days
Trial Locations
- Locations (1)
Pharmaceutical Research Associates, Inc.,
🇺🇸Salt Lake City, Utah, United States