Evaluating how certain drugs affect the safety and effectiveness of EDP-323
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
PHASE1 · Enanta Pharmaceuticals, Inc · NCT06847464
This study is testing how well EDP-323 works and how safe it is when taken with other medications in healthy adults.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Enanta Pharmaceuticals, Inc (industry) |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06847464 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the pharmacokinetics and safety of EDP-323 when administered alongside itraconazole, carbamazepine, quinidine, and fluconazole in healthy adult participants. Each participant's involvement will vary based on the specific part of the study they are enrolled in. The study will involve monitoring how these drugs interact with EDP-323 and their overall impact on the participants' health.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18 to 65 with a BMI between 18 and 30 kg/m2.
Not a fit: Patients with a history of relevant illnesses, pregnant or nursing females, and current tobacco smokers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of drug interactions, leading to safer and more effective treatment regimens for patients.
How similar studies have performed: Other studies have shown success in evaluating drug-drug interactions, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Antonio, Texas
- ICON, plc — San Antonio, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Chris Harris
- Email: charris@enanta.com
- Phone: 1-617-607-0800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: RSV Infection, Drug Drug Interaction