Evaluating how EDP-323 interacts with other drugs in healthy adults
A Non-Randomized, Multiple-Dose, Open-Label, Single Sequence Study to Evaluate the Effect of Concomitant Administration of EDP-323 on the Pharmacokinetics and Safety of Midazolam, Caffeine, and Rosuvastatin in Healthy Participants
This study tests how the drug EDP-323 affects the way healthy adults process other medications like midazolam, caffeine, and rosuvastatin to see if there are any interactions.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Enanta Pharmaceuticals, Inc Industry-sponsored |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06917508 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effects of the drug EDP-323 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy adult participants. It involves administering EDP-323 alongside these medications to observe any potential drug-drug interactions. The study is designed for healthy individuals aged 18 to 65, ensuring a controlled environment to gather accurate data on how EDP-323 influences the metabolism of these drugs. The findings could provide insights into safe medication practices for future treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male and female adults aged 18 to 65 with a body weight over 50 kg and a BMI between 18 and 32.
Not a fit: Patients with a history of significant illness, pregnant or nursing females, or those with conditions affecting drug absorption 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 medication regimens for patients.
How similar studies have performed: While drug-drug interaction studies are common, the specific combination of EDP-323 with these medications is novel and has not been extensively tested.
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 weight \>50 kg and body mass index (BMI) of 18 to 32 kg/m2 * 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 * Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy) * Positive for HIV or hepatitis * Positive urine drug screen * Current tobacco smokers or use of tobacco within 3 months prior to Screening. * Received any vaccine, an investigational agent, or biological product within 28 days or 5 times the t½ of receipt of study drug, whichever is longer. * Drug sensitivity to midazolam, caffeine, rosuvastatin
Where this trial is running
San Antonio, Texas
- ICON, plc — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Chris Harris, MD
- Email: charris@enanta.com
- Phone: 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.