NASH - Nonalcoholic SteatohepatitisPhase 1NCT03610945
Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers
A Phase 1 study testing Fluconazole, Quinidine and EDP-305 in people with NASH - Nonalcoholic Steatohepatitis, run by Enanta Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics and safety of EDP-305 in healthy human volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- Fluconazole, Quinidine and EDP-305
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2018to 21 Aug 2018
- 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.
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
- Female subjects must be of non-childbearing potential.
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.
- Participation in a clinical trial within 30 days prior to the first dose of study drug.
- Clinically significant electrocardiogram abnormalities or QTcF greater than 450 ms for males and 470 ms for females at either Screening or Day -1 (Part 2 only), or any prior history of QT abnormality.
- For Part 2 subjects, the following cardiovascular abnormalities
- QRS duration >110 ms
- Incomplete right bundle branch block or any complete bundle branch block
- Heart rate <40 or >90 beats per minute (per vital sign capture while rested)
- History of unexplained syncope, structural heart disease, or clinically significant arrhythmias
- Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome
- PR interval >220 ms or any 2nd or 3rd degree AV block
- Ventricular pre-excitation
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaceutical Research Associates, Inc.,
Salt Lake City, Utah, 84124
About this study
Official title: A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole and Quinidine on the Pharmacokinetics and Safety of EDP-305 in Healthy Volunteers
This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- Fluconazole, Quinidine, EDP-305
- Keywords
- drug-drug interaction
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
Subjects will receive fluconazole once daily from Day 5 to Day 18
QuinidineDrug
Subjects will receive quinidine twice daily from Day 5 to Day 12
EDP-305Drug
Subjects will receive a single dose of EDP-305 on Day 1 and Day 14
EDP-305Drug
Subjects will receive a single dose of EDP-305 on Day 1 and Day 8
| Study group | Role | What they receive |
|---|---|---|
| EDP-305 and fluconazole interaction (Part 1) | Experimental | Not described Receives: Drug: Fluconazole; Drug: EDP-305 |
| EDP-305 and quinidine interaction (Part 2) | Experimental | Not described Receives: Drug: Quinidine; Drug: EDP-305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of EDP-305 with and without coadministration with fluconazole
Measured: Up to 19 days
AUC of EDP-305 with and without coadministration with fluconazole
Measured: Up to 19 days
Cmax of EDP-305 with and without coadministration with quinidine
Measured: Up to 13 days
AUC of EDP-305 with and without coadministration with quinidine
Measured: Up to 13 days
Secondary outcomes (1)
Safety measured by adverse events
Measured: Up to 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start19 Jul 2018
- Primary completion15 Aug 2018
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies 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
- Model description
- 2-Part Single Group study
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enanta Pharmaceuticals, Inc, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610945
- Sponsor's protocol ID
- EDP 305-007
- Status last verified
- Dec 2018
- First submitted
- 12 Jul 2018
- Last updated
- 5 Dec 2018
- 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 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole and Quinidine on the Pharmacokinetics and Safety of EDP-305 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03610945
- Acronym / sponsor ID
- EDP 305-007
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Keywords
- drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 1 Aug 2018 (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.
This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-Part Single Group study
| Arm | Type | Receives |
|---|---|---|
| EDP-305 and fluconazole interaction (Part 1) | Experimental | Drug: Fluconazole, Drug: EDP-305 |
| EDP-305 and quinidine interaction (Part 2) | Experimental | Drug: Quinidine, Drug: EDP-305 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 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 55 years, inclusive.
- Female subjects must be of non-childbearing potential.
Key exclusion criteria (17 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 |
|---|---|---|
| FluconazoleSubjects will receive fluconazole once daily from Day 5 to Day 18 | Drug | EDP-305 and fluconazole interaction (Part 1) |
| QuinidineSubjects will receive quinidine twice daily from Day 5 to Day 12 | Drug | EDP-305 and quinidine interaction (Part 2) |
| EDP-305Subjects will receive a single dose of EDP-305 on Day 1 and Day 14 | Drug | EDP-305 and fluconazole interaction (Part 1) |
| EDP-305Subjects will receive a single dose of EDP-305 on Day 1 and Day 8 | Drug | EDP-305 and quinidine interaction (Part 2) |
Primary outcome
Cmax of EDP-305 with and without coadministration with fluconazole
Time frame: Up to 19 days
AUC of EDP-305 with and without coadministration with fluconazole
Time frame: Up to 19 days
Cmax of EDP-305 with and without coadministration with quinidine
Time frame: Up to 13 days
AUC of EDP-305 with and without coadministration with quinidine
Time frame: Up to 13 days
1 secondary outcome
Safety measured by adverse events
Time frame: Up to 25 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 5 Dec 2018.
- 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 Fluconazole, Quinidine and EDP-305 in people with NASH - Nonalcoholic Steatohepatitis, 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 3 inclusion and 17 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 5 Dec 2018. 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-305 with and without coadministration with fluconazole (time frame: Up to 19 days). The study lists 4 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 5 Dec 2018.