NASH - Nonalcoholic SteatohepatitisPhase 1NCT03213145
Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers
A Phase 1 study testing intraconazole, Rifampin 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 itraconazole or rifampin 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?
- intraconazole, Rifampin 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
- 11 Jul 2017to 7 Sep 2017
- 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).
- History of regular alcohol consumption.
- Participation in a clinical trial within 30 days prior to the first dose of study drug.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, 66219
About this study
Official title: A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin 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 itraconazole or rifampin on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- intraconazole, Rifampin, 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.
intraconazoleDrug
Subjects will receive itraconazole once daily from Day 5 through Day18
RifampinDrug
Subjects will receive rifampin once daily from Day 5 through Day 16
EDP 305Drug
Subjects will receive EDP 305 once daily on Day 1 and Day 14
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Not described Receives: Drug: intraconazole; Drug: EDP 305 |
| Part 2 | Experimental | Not described Receives: Drug: Rifampin; 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 itraconazole
Measured: Up to 19 days
AUC of EDP-305 with and without coadministration with itraconazole
Measured: Up to 19 days
Cmax of EDP-305 with and without coadministration with rifampin
Measured: Up to 17 days
AUC of EDP-305 with and without coadministration with rifampin
Measured: Up to 17 days
Secondary outcomes (1)
Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).
Measured: Up to 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start11 Jul 2017
- Primary completion10 Aug 2017
- Study completion7 Sep 2017
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, Ind
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213145
- Sponsor's protocol ID
- EDP 305-005
- Status last verified
- Jul 2017
- First submitted
- 7 Jul 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. 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 Itraconazole and Rifampin on the Pharmacokinetics and Safety of EDP-305 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03213145
- Acronym / sponsor ID
- EDP 305-005
- 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
- 11 Jul 2017 (actual)
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 11 Jul 2017 (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 itraconazole or rifampin 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 |
|---|---|---|
| Part 1 | Experimental | Drug: intraconazole, Drug: EDP 305 |
| Part 2 | Experimental | Drug: Rifampin, 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 (8 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 |
|---|---|---|
| intraconazoleSubjects will receive itraconazole once daily from Day 5 through Day18 | Drug | Part 1 |
| RifampinSubjects will receive rifampin once daily from Day 5 through Day 16 | Drug | Part 2 |
| EDP 305Subjects will receive EDP 305 once daily on Day 1 and Day 14 | Drug | Part 1, Part 2 |
Primary outcome
Cmax of EDP-305 with and without coadministration with itraconazole
Time frame: Up to 19 days
AUC of EDP-305 with and without coadministration with itraconazole
Time frame: Up to 19 days
Cmax of EDP-305 with and without coadministration with rifampin
Time frame: Up to 17 days
AUC of EDP-305 with and without coadministration with rifampin
Time frame: Up to 17 days
1 secondary outcome
Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).
Time frame: Up to 19 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 6 Nov 2017.
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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, Ind
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 intraconazole, Rifampin 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 8 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 6 Nov 2017. 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 itraconazole (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 6 Nov 2017.