Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects
- Conditions
- RSV Infection
- Interventions
- Registration Number
- NCT03755778
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Brief Summary
A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Rifampin, and Quinidine on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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.
- Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
- Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938.
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Clinically relevant evidence or history of illness or disease.
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For Part 3 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
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EDP-938 and itraconazole interaction (Part 1) EDP-938 - EDP-938 and quinidine interaction (Part 3) EDP-938 - EDP-938 and rifampin interaction (Part 2) EDP-938 - EDP-938 and itraconazole interaction (Part 1) Itraconazole - EDP-938 and rifampin interaction (Part 2) Rifampin - EDP-938 and quinidine interaction (Part 3) Quinidine -
- Primary Outcome Measures
Name Time Method AUC of EDP-938 with and without coadministration with quinidine Up to 13 days Cmax of EDP-938 with and without coadministration with itraconazole Up to 19 days AUC of EDP-938 with and without coadministration with itraconazole Up to 19 days Cmax of EDP-938 with and without coadministration with rifampin Up to 17 days AUC of EDP-938 with and without coadministration with rifampin Up to 17 days Cmax of EDP-938 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.,
🇺🇸Lenexa, Kansas, United States