NCT03755778CompletedPhase 1
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
Enanta Pharmaceuticals, Inc1 site in 1 country72 target enrollmentStarted: November 29, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enanta Pharmaceuticals, Inc
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Cmax of EDP-938 with and without coadministration with itraconazole
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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.
- •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.
Exclusion Criteria
- •Clinically relevant evidence or history of illness or disease.
- •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
- •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 -
- •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.
Arms & Interventions
EDP-938 and rifampin interaction (Part 2)
Experimental
Intervention: Rifampin (Drug)
EDP-938 and itraconazole interaction (Part 1)
Experimental
Intervention: EDP-938 (Drug)
EDP-938 and itraconazole interaction (Part 1)
Experimental
Intervention: Itraconazole (Drug)
EDP-938 and rifampin interaction (Part 2)
Experimental
Intervention: EDP-938 (Drug)
EDP-938 and quinidine interaction (Part 3)
Experimental
Intervention: EDP-938 (Drug)
EDP-938 and quinidine interaction (Part 3)
Experimental
Intervention: Quinidine (Drug)
Outcomes
Primary Outcomes
Cmax of EDP-938 with and without coadministration with itraconazole
Time Frame: Up to 19 days
AUC of EDP-938 with and without coadministration with itraconazole
Time Frame: Up to 19 days
Cmax of EDP-938 with and without coadministration with rifampin
Time Frame: Up to 17 days
AUC of EDP-938 with and without coadministration with rifampin
Time Frame: Up to 17 days
Cmax of EDP-938 with and without coadministration with quinidine
Time Frame: Up to 13 days
AUC of EDP-938 with and without coadministration with quinidine
Time Frame: Up to 13 days
Secondary Outcomes
- Safety measured by adverse events(Up to 25 days)
Investigators
Study Sites (1)
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