Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pharmaceutical Research Associates | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects.
Part 2 is randomized, double -blind, placebo-controlled study including subjects with Hepatitis B Virus. It will assess the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days of orally administered doses of EDP-514 in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection
Part 1 consists of two phases planned in healthy subjects:
The first phase assesses single ascending doses for EDP-514 (active drug or placebo) in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.
The second phase assesses multiple ascending doses (active drug or placebo) for 14 days in healthy subjects.
Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-514 or placebo.
Part 2 assesses multiple ascending doses EDP-514 (active drug or placebo) for 28 days in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection.
Each cohort in Part 2 will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| EDP-514 HBV MAD Cohorts | Experimental | EDP-514 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP-514 | Drug | Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by adverse events | Up to 8 Days in HV SAD Cohorts | |
| Safety measured by adverse events | Up to 21 Days in HV MAD Cohorts | |
| Safety measured by adverse events | Up to 56 Days in HBV MAD Cohorts |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP-514 | Up to 6 Days in HV SAD Cohorts | |
| AUC of EDP-514 | Up to 6 Days in HV SAD Cohorts | |
| Cmax of EDP-514 |
Not provided
Part 1 (HV Population):
Inclusion Criteria:
Exclusion Criteria:
Part 2 (HBV Population):
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 70 years, inclusive
HBV DNA levels:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Enanta Pharmaceuticals, Inc | Enanta Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California GI and Liver Centers | Coronado | California | 92118 | United States | ||
| University of California Los Angeles |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo to match EDP-514 |
|
| Up to 18 Days in HV MAD Cohorts |
| AUC of EDP-514 | Up to 18 Days in HV MAD Cohorts |
| Cmax of EDP-514 | Up to 28 Days in HBV MAD Cohorts |
| AUC of EDP-514 | Up to 28 Days in HBV MAD Cohorts |
| Los Angeles |
| California |
| 90095 |
| United States |
| Tuan Nguyen Md Gastroenterology & Hepatology (Tuan Nguyen, M.D., Inc.) | San Diego | California | 92105 | United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| Pharmaceutical Research Associates, Inc. | Lenexa | Kansas | 66219 | United States |
| Digestive Disease Associates - Catonsville | Catonsville | Maryland | 21228 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| American Research Corporation | Houston | Texas | 77030 | United States |
| The Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Swedish Organ Transplant and Liver Center | Seattle | Washington | 98104 | United States |
| University Of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| Gastroenterology Institute of Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 0A9 | Canada |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided