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

Last updated: February 21, 2025
Sponsor: Enanta Pharmaceuticals, Inc
Overall Status: Active - Recruiting

Phase

1

Condition

Respiratory Syncytial Virus (Rsv) Infection

Respiratory Syncytial Virus (Rsv)

Treatment

Quinidine

EDP-323

carbamazepine

Clinical Study ID

NCT06847464
EDP 323-005
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 65years, 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 ofcontraception from the date of Screening until 30 days after the last dose ofEDP-323. A male participant who has not had a vasectomy and is sexually active witha woman of childbearing potential must agree to use effective contraception from thedate of Screening to 90 days after his last dose of study drug.

Exclusion

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 orsubjects 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 studydrug

  • 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 significantarrhythmias

  • Personal or family history of long QT syndrome (genetically proven or suggested bysudden death of a close relative due to cardiac causes at a young age) or Brugadasyndrome

  • 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, dueto reported incidence of agranulocytosis and aplastic anemia with carbamazepine

Study Design

Total Participants: 48
Treatment Group(s): 5
Primary Treatment: Quinidine
Phase: 1
Study Start date:
January 27, 2025
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • ICON, plc

    San Antonio, Texas 78209
    United States

    Active - Recruiting

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