Clinical trial NCT06847464: A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323.
Official title: A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine, and Fluconazole on the Pharmacokinetics and Safety of EDP-323 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: RSV Infection
Drug Drug Interaction (DDI)
Keywords: Drug Drug Interaction
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary aim of the study is to assess the effect of itraconazole, carbamazepine, quinidine, and fluconazole individually on the pharmacokinetics and safety of EDP-323 in healthy adult participants. Each participant's duration in the study will be dependent upon which study part they are enrolled.


Eligibility criteria: 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 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:

* 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 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

Primary outcomes:
measure: Cmax of EDP-323 with and without coadministration with Itraconazole
timeFrame: Day 1 through Day 19
measure: AUC of EDP-323 with and without coadministration with Itraconazole
timeFrame: Day 1 through Day 19
measure: Cmax of EDP-323 with and without coadministration with Carbamazepine
timeFrame: Day 1 through Day 28
measure: AUC of EDP-323 with and without coadministration with Carbamazepine
timeFrame: Day 1 through Day 28
measure: Cmax of EDP-323 with and without coadministration with Quinidine
timeFrame: Day 1 through Day 13
measure: AUC of EDP-323 with and without coadministration with Quinidine
timeFrame: Day 1 through Day 13
measure: Cmax of EDP-323 with and without coadministration with fluconazole
timeFrame: Day 1 through Day 19
measure: AUC of EDP-323 with and without coadministration with fluconazole
timeFrame: Day 1 through Day 19
Secondary outcomes:
measure: Safety measured by adverse events
timeFrame: Up to 34 Days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON, plc
state: Texas
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References: