Hepatitis BPhase 1NCT04783753
Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects
A Phase 1 study testing EDP-514, Itraconazole and Carbamazepin in people with Hepatitis B, run by Enanta Pharmaceuticals, Inc at 1 site in United States.
Trial summary
Non-randomized, 3-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of itraconazole, carbamazepine, or quinidine on the PK and safety of EDP-514 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- EDP-514, Itraconazole and Carbamazepin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to 9 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 contraception from the date of Screening until 30 days after the last dose of EDP-514.
- Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg.
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 clinically significant active infection.
- A positive urine drug screen at Screening or Day -1.
- Current tobacco smokers or use of tobacco products within 3 months prior to Screening.
- Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
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- Clinically significant laboratory abnormalities at screening or Day -1, as determined by the Investigator (including but not limited to hypokalemia, hypocalcemia, or hypomagnesemia for Part 3 participants).
- History of regular alcohol consumption
- Participation in a clinical trial within 30 days prior to the first dose of study drug.
- For Part 2 (Carbamazepine) participants:
- Participants of Asian ancestry, given association of carbamazepine and severe rash (Stevens Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) with HLA-B 1502 in this population.
- Platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaceutical Research Association
Lenexa, Kansas, 66219
About this study
Official title: A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, and Quinidine on the Pharmacokinetics and Safety of EDP-514 in Healthy Subjects
Non-randomized, 3-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of itraconazole, carbamazepine, or quinidine on the PK and safety of EDP-514 in healthy adult subjects.
- Conditions
- Hepatitis B
- Being tested
- EDP-514, Itraconazole, Carbamazepin, Quinidine
- Keywords
- drug-drug interaction
- 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
Subjects will receive EDP-514 on Days 1 and 14
EDP-514Drug
Subjects will receive EDP-514 on Days 1 and 23
EDP-514Drug
Subjects will receive EDP-514 on Days 1 and 8
ItraconazoleDrug
Subjects will receive itraconazole QD for 14 days
CarbamazepinDrug
Subjects will receive carbamazepine BID for 23 days
QuinidineDrug
Subjects will receive quinidine BID for 8 days
| Study group | Role | What they receive |
|---|---|---|
| EDP-514 and Itraconazole interaction (Part 1) | Experimental | Not described Receives: Drug: EDP-514; Drug: Itraconazole |
| EDP-514 and Carbamazepine interaction (Part 2) | Experimental | Not described Receives: Drug: EDP-514; Drug: Carbamazepin |
| EDP-514 and Quinidine interaction (Part 3) | Experimental | Not described Receives: Drug: EDP-514; Drug: Quinidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of EDP-514 with and without coadministration with itraconazole
Measured: up to 19 days
AUC of EDP-514 with and without coadministration with itraconazole
Measured: 19 days
Cmax of EDP-514 with and without coadministration with carbamazepine
Measured: up to 28 days
AUC of EDP-514 with and without coadministration with carbamazepine
Measured: up to 28 days
Cmax of EDP-514 with and without coadministration with quinidine
Measured: up to 13 days
AUC of EDP-514 with and without coadministration with quinidine
Measured: up to 13 days
Secondary outcomes (1)
Safety measured by adverse events
Measured: up to 34 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start5 Nov 2020
- Primary completion28 Jun 2021
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Enanta Pharmaceuticals, Inc, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783753
- Sponsor's protocol ID
- EDP 514-003
- Status last verified
- Aug 2021
- First submitted
- 2 Mar 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, and Quinidine on the Pharmacokinetics and Safety of EDP-514 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04783753
- Acronym / sponsor ID
- EDP 514-003
- Conditions
- Hepatitis B
- Keywords
- drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 5 Mar 2021 (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.
Non-randomized, 3-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of itraconazole, carbamazepine, or quinidine on the PK and safety of EDP-514 in healthy adult subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EDP-514 and Itraconazole interaction (Part 1) | Experimental | Drug: EDP-514, Drug: Itraconazole |
| EDP-514 and Carbamazepine interaction (Part 2) | Experimental | Drug: EDP-514, Drug: Carbamazepin |
| EDP-514 and Quinidine interaction (Part 3) | Experimental | Drug: EDP-514, Drug: Quinidine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 contraception from the date of Screening until 30 days after the last dose of EDP-514.
- Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg.
Key exclusion criteria (12 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 clinically significant active infection.
- A positive urine drug screen at Screening or Day -1.
- Current tobacco smokers or use of tobacco products 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-514Subjects will receive EDP-514 on Days 1 and 14 | Drug | EDP-514 and Itraconazole interaction (Part 1) |
| EDP-514Subjects will receive EDP-514 on Days 1 and 23 | Drug | EDP-514 and Carbamazepine interaction (Part 2) |
| EDP-514Subjects will receive EDP-514 on Days 1 and 8 | Drug | EDP-514 and Quinidine interaction (Part 3) |
| ItraconazoleSubjects will receive itraconazole QD for 14 days | Drug | EDP-514 and Itraconazole interaction (Part 1) |
| CarbamazepinSubjects will receive carbamazepine BID for 23 days | Drug | EDP-514 and Carbamazepine interaction (Part 2) |
| QuinidineSubjects will receive quinidine BID for 8 days | Drug | EDP-514 and Quinidine interaction (Part 3) |
Primary outcome
Cmax of EDP-514 with and without coadministration with itraconazole
Time frame: up to 19 days
AUC of EDP-514 with and without coadministration with itraconazole
Time frame: 19 days
Cmax of EDP-514 with and without coadministration with carbamazepine
Time frame: up to 28 days
AUC of EDP-514 with and without coadministration with carbamazepine
Time frame: up to 28 days
Cmax of EDP-514 with and without coadministration with quinidine
Time frame: up to 13 days
AUC of EDP-514 with and without coadministration with quinidine
Time frame: up to 13 days
1 secondary outcome
Safety measured by adverse events
Time frame: up to 34 days
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 16 Aug 2021.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EDP-514, Itraconazole and Carbamazepin in people with Hepatitis B, run by Enanta Pharmaceuticals, Inc at 1 site in United States.
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 4 inclusion and 12 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 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
Cmax of EDP-514 with and without coadministration with itraconazole (time frame: up to 19 days). The study lists 6 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 16 Aug 2021.