Chronic HBV InfectionPhase 1NCT04008004
A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
A Phase 1 study testing EDP-514 in people with Chronic HBV Infection, run by Enanta Pharmaceuticals, Inc at 15 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic HBV Infection
- What is being tested?
- EDP-514
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 26 Jun 2019to 14 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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).
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- 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):
- 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
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States11 sites
Digestive Disease Associates - Catonsville
Catonsville, Maryland, 21228
Southern California GI and Liver Centers
Coronado, California, 92118
American Research Corporation
Houston, Texas, 77030
Pharmaceutical Research Associates, Inc.
Lenexa, Kansas, 66219
University of California Los Angeles
Los Angeles, California, 90095
University of Miami Miller School of Medicine
Miami, Florida, 33136
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
The Texas Liver Institute
San Antonio, Texas, 78215
Tuan Nguyen Md Gastroenterology & Hepatology (Tuan Nguyen, M.D., Inc.)
San Diego, California, 92105
Quest Clinical Research
San Francisco, California, 94115
Swedish Organ Transplant and Liver Center
Seattle, Washington, 98104
Canada4 sites
University Of Calgary
Calgary, Alberta, T2N 4Z6
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Gastroenterology Institute of Research Institute
Vancouver, British Columbia, V6Z 2K5
About this study
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)
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
Read the 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.
- Conditions
- Chronic HBV Infection
- Being tested
- EDP-514, Placebo
- Keywords
- "First-in-Human", Single Ascending Dose, Multiple Ascending Dose, hepatitis B virus, HBV
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP-514Drug
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).
PlaceboDrug
Placebo to match EDP-514
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: EDP-514 |
| EDP-514 HV MAD Cohorts | Experimental | EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days Receives: Drug: EDP-514 |
| EDP-514 HV SAD Placebo Cohort | Placebo comparator | Matching placebo, orally, once daily in one single administration Receives: Drug: Placebo |
| EDP-514 HV MAD Placebo Cohort | Placebo comparator | Matching placebo, orally, once daily for 14 days Receives: Drug: Placebo |
| EDP-514 HBV MAD Cohorts | Experimental | EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days Receives: Drug: EDP-514 |
| EDP-514 HBV MAD Placebo Cohort | Placebo comparator | Matching placebo, orally, once daily for 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by adverse events
Measured: Up to 8 Days in HV SAD Cohorts
Safety measured by adverse events
Measured: Up to 21 Days in HV MAD Cohorts
Safety measured by adverse events
Measured: Up to 56 Days in HBV MAD Cohorts
Secondary outcomes (6)
Cmax of EDP-514
Measured: Up to 6 Days in HV SAD Cohorts
AUC of EDP-514
Measured: Up to 6 Days in HV SAD Cohorts
Cmax of EDP-514
Measured: Up to 18 Days in HV MAD Cohorts
AUC of EDP-514
Measured: Up to 18 Days in HV MAD Cohorts
Cmax of EDP-514
Measured: Up to 28 Days in HBV MAD Cohorts
AUC of EDP-514
Measured: Up to 28 Days in HBV MAD Cohorts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start26 Jun 2019
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HBV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates
- Responsible party
- Sponsor
- Investigators
- Enanta Pharmaceuticals, Inc, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008004
- Sponsor's protocol ID
- EDP 514-001
- Status last verified
- May 2021
- First submitted
- 2 Jul 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04008004
- Acronym / sponsor ID
- EDP 514-001
- Conditions
- Chronic HBV Infection
- Keywords
- "First-in-Human", Single Ascending Dose, Multiple Ascending Dose, hepatitis B virus, HBV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| EDP-514 HV SAD Cohorts | Experimental | Drug: EDP-514EDP-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 | Drug: EDP-514EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days |
| EDP-514 HV SAD Placebo Cohort | Placebo comparator | Drug: PlaceboMatching placebo, orally, once daily in one single administration |
| EDP-514 HV MAD Placebo Cohort | Placebo comparator | Drug: PlaceboMatching placebo, orally, once daily for 14 days |
| EDP-514 HBV MAD Cohorts | Experimental | Drug: EDP-514EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days |
| EDP-514 HBV MAD Placebo Cohort | Placebo comparator | Drug: PlaceboMatching placebo, orally, once daily for 28 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDP-514Oral 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). | Drug | EDP-514 HBV MAD Cohorts, EDP-514 HV MAD Cohorts, EDP-514 HV SAD Cohorts |
| PlaceboPlacebo to match EDP-514 | Drug | EDP-514 HBV MAD Placebo Cohort, EDP-514 HV MAD Placebo Cohort, EDP-514 HV SAD Placebo Cohort |
Primary outcome
Safety measured by adverse events
Time frame: Up to 8 Days in HV SAD Cohorts
Safety measured by adverse events
Time frame: Up to 21 Days in HV MAD Cohorts
Safety measured by adverse events
Time frame: Up to 56 Days in HBV MAD Cohorts
6 secondary outcomes
Cmax of EDP-514
Time frame: Up to 6 Days in HV SAD Cohorts
AUC of EDP-514
Time frame: Up to 6 Days in HV SAD Cohorts
Cmax of EDP-514
Time frame: Up to 18 Days in HV MAD Cohorts
AUC of EDP-514
Time frame: Up to 18 Days in HV MAD Cohorts
Cmax of EDP-514
Time frame: Up to 28 Days in HBV MAD Cohorts
AUC of EDP-514
Time frame: Up to 28 Days in HBV MAD Cohorts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enanta Pharmaceuticals, Inc study director
Enanta Pharmaceuticals, Inc
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EDP-514 in people with Chronic HBV Infection, run by Enanta Pharmaceuticals, Inc at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by adverse events (time frame: Up to 8 Days in HV SAD Cohorts). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.