Back to resultsA Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
Primary Purpose
Chronic HBV Infection
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
EDP-514
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic HBV Infection focused on measuring "First-in-Human", Single Ascending Dose, Multiple Ascending Dose, hepatitis B virus, HBV
Eligibility Criteria
Part 1 (HV 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 65 years, inclusive.
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.
- Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose. This includes agents administered during clinical trial participation.
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:
- A Screening HBV DNA level in serum/plasma that is <LLOQ and
- No HBV DNA serum/plasma test values ≥LLOQ over the previous 12 months (using an approved test)
- CHB subjects must have been on their prescribed HBV NUC treatment with no change in regimen for 12 months prior to Screening
Exclusion Criteria:
- A documented prior diagnosis of cirrhosis
- Pregnant or nursing females
- Coinfection with human immunodeficiency virus (HIV), HCV, HDV, HAV, or HEV
- Chronic liver disease of a non-HBV etiology; coexisting liver or biliary diseases
Sites / Locations
- Southern California GI and Liver Centers
- University of California Los Angeles
- Tuan Nguyen Md Gastroenterology & Hepatology (Tuan Nguyen, M.D., Inc.)
- Quest Clinical Research
- University of Miami Miller School of Medicine
- Pharmaceutical Research Associates, Inc.
- Digestive Disease Associates - Catonsville
- Icahn School of Medicine at Mount Sinai
- American Research Corporation
- The Texas Liver Institute
- Swedish Organ Transplant and Liver Center
- University Of Calgary
- Gastroenterology Institute of Research Institute
- Toronto General Hospital
- Centre Hospitalier de l'Université de Montréal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
EDP-514 HV SAD Cohorts
EDP-514 HV MAD Cohorts
EDP-514 HV SAD Placebo Cohort
EDP-514 HV MAD Placebo Cohort
EDP-514 HBV MAD Cohorts
EDP-514 HBV MAD Placebo Cohort
Arm Description
EDP-514 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 orally, once daily in one single administration
EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days
Matching placebo, orally, once daily in one single administration
Matching placebo, orally, once daily for 14 days
EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days
Matching placebo, orally, once daily for 28 days
Outcomes
Primary Outcome Measures
Safety measured by adverse events
Safety measured by adverse events
Safety measured by adverse events
Secondary Outcome Measures
Cmax of EDP-514
AUC of EDP-514
Cmax of EDP-514
AUC of EDP-514
Cmax of EDP-514
AUC of EDP-514
Full Information
NCT ID
NCT04008004
First Posted
July 2, 2019
Last Updated
January 6, 2022
Sponsor
Enanta Pharmaceuticals, Inc
Collaborators
Pharmaceutical Research Associates
1. Study Identification
Unique Protocol Identification Number
NCT04008004
Brief Title
A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
Official Title
A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EDP 514 in Healthy Subjects (Part 1), and Antiviral Activity in Nucleos(t)Ide Reverse Transcriptase Inhibitor (NUC)-Suppressed Patients With Chronic Hepatitis B Virus Infection (Part 2)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
July 14, 2021 (Actual)
Study Completion Date
July 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enanta Pharmaceuticals, Inc
Collaborators
Pharmaceutical Research Associates
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic HBV Infection
Keywords
"First-in-Human", Single Ascending Dose, Multiple Ascending Dose, hepatitis B virus, HBV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EDP-514 HV SAD Cohorts
Arm Type
Experimental
Arm Description
EDP-514 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 orally, once daily in one single administration
Arm Title
EDP-514 HV MAD Cohorts
Arm Type
Experimental
Arm Description
EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days
Arm Title
EDP-514 HV SAD Placebo Cohort
Arm Type
Placebo Comparator
Arm Description
Matching placebo, orally, once daily in one single administration
Arm Title
EDP-514 HV MAD Placebo Cohort
Arm Type
Placebo Comparator
Arm Description
Matching placebo, orally, once daily for 14 days
Arm Title
EDP-514 HBV MAD Cohorts
Arm Type
Experimental
Arm Description
EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days
Arm Title
EDP-514 HBV MAD Placebo Cohort
Arm Type
Placebo Comparator
Arm Description
Matching placebo, orally, once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
EDP-514
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match EDP-514
Primary Outcome Measure Information:
Title
Safety measured by adverse events
Time Frame
Up to 8 Days in HV SAD Cohorts
Title
Safety measured by adverse events
Time Frame
Up to 21 Days in HV MAD Cohorts
Title
Safety measured by adverse events
Time Frame
Up to 56 Days in HBV MAD Cohorts
Secondary Outcome Measure Information:
Title
Cmax of EDP-514
Time Frame
Up to 6 Days in HV SAD Cohorts
Title
AUC of EDP-514
Time Frame
Up to 6 Days in HV SAD Cohorts
Title
Cmax of EDP-514
Time Frame
Up to 18 Days in HV MAD Cohorts
Title
AUC of EDP-514
Time Frame
Up to 18 Days in HV MAD Cohorts
Title
Cmax of EDP-514
Time Frame
Up to 28 Days in HBV MAD Cohorts
Title
AUC of EDP-514
Time Frame
Up to 28 Days in HBV MAD Cohorts
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Part 1 (HV 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 65 years, inclusive.
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.
Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose. This includes agents administered during clinical trial participation.
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:
A Screening HBV DNA level in serum/plasma that is <LLOQ and
No HBV DNA serum/plasma test values ≥LLOQ over the previous 12 months (using an approved test)
CHB subjects must have been on their prescribed HBV NUC treatment with no change in regimen for 12 months prior to Screening
Exclusion Criteria:
A documented prior diagnosis of cirrhosis
Pregnant or nursing females
Coinfection with human immunodeficiency virus (HIV), HCV, HDV, HAV, or HEV
Chronic liver disease of a non-HBV etiology; coexisting liver or biliary diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enanta Pharmaceuticals, Inc
Organizational Affiliation
Enanta Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Southern California GI and Liver Centers
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Tuan Nguyen Md Gastroenterology & Hepatology (Tuan Nguyen, M.D., Inc.)
City
San Diego
State/Province
California
ZIP/Postal Code
92105
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Pharmaceutical Research Associates, Inc.
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Digestive Disease Associates - Catonsville
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
American Research Corporation
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Swedish Organ Transplant and Liver Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University Of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Gastroenterology Institute of Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
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