A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323.

Description

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.

Conditions

RSV Infection, Drug Drug Interaction (DDI)

Study Overview

Study Details

Study overview

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.

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

A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323.

Condition
RSV Infection
Intervention / Treatment

-

Contacts and Locations

San Antonio

ICON, plc, San Antonio, Texas, United States, 78209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Enanta Pharmaceuticals, Inc,

Enanta Pharmaceuticals, Inc, STUDY_DIRECTOR, Enanta Pharmaceuticals, Inc

Study Record Dates

2025-06