Investigating the effects of zelicapavir on heart rhythm in healthy adults
Phase 1, Randomized, Double-Blind Four-Period Crossover, Thorough QT/QTc Study to Evaluate the Effects of EDP-938 on Cardiac Repolarization in Healthy Adults
This study tests how different doses of a new drug called zelicapavir affect heart rhythm in healthy adults aged 18 to 65.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Enanta Pharmaceuticals, Inc Industry-sponsored |
| Locations | 2 sites (Lenexa, Kansas and 1 other locations) |
| Trial ID | NCT06601192 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how different doses of zelicapavir affect the corrected QT interval of the heart in healthy adult participants. It will compare the effects of therapeutic and supratherapeutic doses of the drug against a placebo and a positive control, moxifloxacin. The study will involve healthy individuals aged 18 to 65, who will be monitored for any changes in heart rhythm during the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with a BMI between 18 and 30 kg/m2.
Not a fit: Patients with a history of cardiovascular abnormalities or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the cardiac safety profile of zelicapavir, potentially leading to safer treatment options for patients with RSV infections.
How similar studies have performed: Other studies have explored the cardiac effects of antiviral medications, but the specific approach of this study with zelicapavir is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * An informed consent document signed and dated by the subject. * Male or female individuals who are 18 to 65 years of age, inclusive * Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg * Heterosexually active male participants and their female partners of childbearing potential must agree to use 2 effective birth control methods for the duration of the study and for 90 days after the last dose of study intervention. * Females of childbearing potential must agree to use 2 effective birth control methods for the duration of the study and for 30 days after the last dose of study intervention. Exclusion Criteria: * Clinically relevant evidence or history of illness or disease * Clinically relevant risk factors for cardiovascular abnormalities * 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 * Infection with HIV, HBV, HCV, or SARS CoV 2 * Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy) * Before the first dose of study intervention, participant has received any vaccine, an investigational agent or biological product within 28 days or 5 times the terminal half-life (t½), whichever is longer * A positive urine drug screen at Screening or Day -1 * Current tobacco smokers or use of tobacco within 3 months prior to Screening * History of regular alcohol consumption
Where this trial is running
Lenexa, Kansas and 1 other locations
- Icon — Lenexa, Kansas, United States (Recruiting)
- ICON Early Phase, LLC — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Paola Castellotti, MD
- Email: pcastellotti@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.