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

Launched by ENANTA PHARMACEUTICALS, INC · Feb 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how four different medications—itraconazole, carbamazepine, quinidine, and fluconazole—affect the way a new drug called EDP-323 is processed in the body. The main goal is to see if these medications change how safe and effective EDP-323 is for treating RSV (Respiratory Syncytial Virus) infections. The study is currently looking for healthy adults aged 18 to 65 who meet certain health criteria, including a normal body weight and no significant medical issues.

Participants in the trial will take EDP-323 along with one of the other medications, and their time in the study will vary based on which part they are involved in. They will need to provide informed consent and agree to use effective birth control if they are of childbearing age. It's important to note that individuals with certain health conditions, such as significant heart problems or recent infections, cannot participate. Overall, participants can expect close monitoring of their health while contributing to important research on RSV treatment.

Gender

ALL

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