A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323.
NCT ID: NCT06847464
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2025-01-27
2025-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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EDP-323 and itraconazole interaction (Part 1)
Subjects will receive EDP-323 and itraconazole on respective dosing days
EDP-323
Subjects will receive EDP-323 on Days 1 and 14
Itraconazole
Subjects will receive itraconazole QD Days 5-18
EDP-323 and carbamazepine interaction (Part 2)
Subjects will receive EDP-323 and carbamazepine on respective dosing days
EDP-323
Subjects will receive EDP-323 on Days 1 and 23
carbamazepine
Subjects will receive carbamazepine on Days 5 - 27
EDP-323 and quinidine interaction (Part 3)
Subjects will receive EDP-323 and quinidine on respective dosing days
EDP-323
Subjects will receive EDP-323 on Days 1 and 8
Quinidine
Subjects will receive quinidine on Days 5-12
EDP-323 and fluconazole interaction (Part 4)
Subjects will receive EDP-323 and fluconazole on respective dosing days
EDP-323
Subjects will receive EDP-323 on Days 1 and 14
fluconazole
Subjects will receive fluconazole on Days 5-18
Interventions
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EDP-323
Subjects will receive EDP-323 on Days 1 and 14
Itraconazole
Subjects will receive itraconazole QD Days 5-18
EDP-323
Subjects will receive EDP-323 on Days 1 and 23
carbamazepine
Subjects will receive carbamazepine on Days 5 - 27
EDP-323
Subjects will receive EDP-323 on Days 1 and 8
Quinidine
Subjects will receive quinidine on Days 5-12
EDP-323
Subjects will receive EDP-323 on Days 1 and 14
fluconazole
Subjects will receive fluconazole on Days 5-18
Eligibility Criteria
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Inclusion Criteria
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.
* Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of50 kg
* Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of EDP-323. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.
Exclusion Criteria
* 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 exceeding protocol limits
* Participation in a clinical trial within 28 days prior to the first dose of study drug
* For Part 2 and Part 3 participants, 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
* Other exclusions for Part 2 (carbamazepine) participants
* Participants of Asian ancestry with HLA allele B\*1502 in this population
* Platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine
18 Years
65 Years
ALL
Yes
Sponsors
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Enanta Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Enanta Pharmaceuticals, Inc
Role: STUDY_DIRECTOR
Enanta Pharmaceuticals, Inc
Locations
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ICON, plc
San Antonio, Texas, United States
Countries
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Other Identifiers
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EDP 323-005
Identifier Type: -
Identifier Source: org_study_id
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