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EDP-514 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| EDP-514 and Itraconazole interaction (Part 1) | EXPERIMENTAL | - |
| EDP-514 and Carbamazepine interaction (Part 2) | EXPERIMENTAL | - |
| EDP-514 and Quinidine interaction (Part 3) | EXPERIMENTAL | - |
| EDP-514 HBV MAD Cohorts | EXPERIMENTAL | EDP-514 capsule Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days. |
| EDP-514 HBV MAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, orally, once daily for 28 days. |
| EDP-514 HV SAD Cohorts | EXPERIMENTAL | EDP-514 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 orally, once daily in one single administration |
| EDP-514 HV MAD Cohorts | EXPERIMENTAL | EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days |
| EDP-514 HV SAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, orally, once daily in one single administration |
| EDP-514 HV MAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, orally, once daily for 14 days |
| Name | Type | Description |
|---|---|---|
| EDP-514 | DRUG | Subjects will receive EDP-514 on Days 1 and 14 |
| Itraconazole | DRUG | Subjects will receive itraconazole QD for 14 days |
| Carbamazepin | DRUG | Subjects will receive carbamazepine BID for 23 days |
| Quinidine | DRUG | Subjects will receive quinidine BID for 8 days |
| Placebo | DRUG | Placebo to match EDP-514 |
Inclusion Criteria: * An informed consent document signed and dated by the subject. * Male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive * Female subjects who are heterosexually active and of childbearing potential must agree to use two effective methods of...
EDP-514 is an investigational small molecule being developed for the treatment of chronic hepatitis B virus infection, also known as chronic HBV infection. It is being studied in patients with chronic HBV who are not currently on treatment, as well as in healthy volunteers in clinical pharmacology studies.
EDP-514 targets the hepatitis B virus core protein and is classified as a core inhibitor. Core inhibitors are designed to interfere with the assembly and function of the viral nucleocapsid, a key step in the HBV replication cycle. EDP-514 is a small molecule developed by Enanta Pharmaceuticals.
EDP-514 is being developed by Enanta Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol ENTA. Enanta is the sponsor of the clinical studies evaluating EDP-514 in chronic hepatitis B virus infection and in healthy volunteers.
EDP-514 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 program includes completed studies in healthy volunteers and in patients with chronic hepatitis B virus infection.
EDP-514 has been evaluated in completed Phase 1 trials, including NCT04783753, a drug-drug interaction study in healthy subjects; NCT04470388, a study in patients with chronic HBV infection not currently on treatment; and NCT04008004, a study in healthy subjects and patients with chronic HBV infection.
Across the completed Phase 1 studies of EDP-514, a total of 124 participants have been enrolled. These trials included both healthy volunteers and patients with chronic hepatitis B virus infection, and the studies were randomized, double-blind, and placebo-controlled.