Hepatitis CPhase 1NCT02652377
EDP-494-001: A Study of EDP-494 in Healthy Subjects and Hepatitis C Patients
A Phase 1 study testing EDP-494 in people with Hepatitis C, run by Enanta Pharmaceuticals, Inc at 1 site in New Zealand.
Trial summary
This randomized, double-blind study will assess the safety, pharmacokinetics and efficacy of a single and multiple dose(s) of orally QD administered EDP-494 in healthy volunteers (HV) and in treatment-naive subjects with GT1/3 chronic hepatitis C (CHC) infection. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- EDP-494
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNew Zealand
- Study dates
- 10 Jan 2016to 27 Dec 2016
- 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
- Males and females aged 18 years and less than 70 years.
- Female subjects must be of non-childbearing potential.
- All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug.
- Body mass index of 18 to 36 kg/m2 with a minimum body weight of 50 kg.
- Treatment naïve subjects with chronic HCV infection,
- HCV GT1 (including 1a, 1b, or mixed subtypes of GT1) or GT3.
- HCV RNA ≥100,000 IU/mL at screening.
- An informed consent document signed and dated by the subject.
Who cannot join
- Women of childbearing potential (WOCBP).
- Pregnant or nursing females.
- History of febrile illness within 7 days prior to the first dose of study drug.
- A positive urine drug screen at screening unless on an approved prescription.
- History of participation in a clinical trial with a polymerase inhibitor or previous treatment with a polymerase inhibitor, where at least one dose of the polymerase inhibitor was consumed. Subjects who were dosed with placebo on a clinical trial may be enrolled in this study.
- Clinically significant electrocardiogram abnormalities or QTcF greater than 450 msec for males and 470 msec for females at either screening or baseline, or any prior history of QT abnormality.
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- Co-infection with HIV-1, HIV-2 or HBV.
- Have clinically significant laboratory abnormalities at screening:
- Absolute neutrophil count (ANC) < 1500/mm2 (1.5 x 109L)
- Platelets <90,000/mm2 (90 x 109L)
- Hemoglobin < 13g/dL for males and < 12g/dL for females
- Serum creatinine >1.5 x upper limit of normal (ULN) or creatinine clearance < 50 mL/min; estimated by the cockcroft -Gault formula [(140-age) x weight (kg)/72 x serum creatinine (mg/dL), if female multiply by 0.85]
- Total bilirubin greater than the ULN
- Serum alanine transaminase (ALT) > 5 x ULN
- Serum aspartate aminotransferase (AST) > 5 x ULN
- Alkaline phosphatase > 1.25 x ULN
- Pancreatic Amylase > 1.1 x ULN
- Alpha fetoprotein (AFP) > 50 ng/mL unless a liver imaging study (CT, MRI) shows no clinically significant lesions within 6 months prior to the first dose of study drug.
- Patients with evidence of cirrhosis; cirrhosis is defined as any one of the following: a) any biopsy showing cirrhosis (Knodell score <3, Metavir score <3, Ishak score <4); b) Fibroscan evaluation within 6 months prior to screening with a liver stiffness score of ><12.5 kPa.
- Other significant, unstable or uncontrolled medical history, such as neurological, endocrine, malignancy, renal, psychiatric, respiratory, cardiac, gastrointestinal, allergic, immunological, etc. disease.
- Use of concomitant medications, including vitamins or herbal and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Pbo-Controlled, Study of EDP-494 to Evaluate the Safety and PK of SAD/FE in Healthy Subjects and MAD in Healthy and in Subjects With CHC Infection (POC)
This randomized, double-blind study will assess the safety, pharmacokinetics and efficacy of a single and multiple dose(s) of orally QD administered EDP-494 in healthy volunteers (HV) and in treatment-naive subjects with GT1/3 chronic hepatitis C (CHC) infection.
Read the detailed description
The first phase explores single ascending doses of EDP-494 (active drug or placebo) in healthy subjects. A 'fasted' vs 'fed' two-part cohort will also assess food effect.
The second phase involves multiple ascending doses (active drug or placebo) for 14 days in healthy subjects.
The third, proof of concept, phase will assess two different doses for 14 days each in Hepatitis C patients.
Each cohort within each phase will consist of 8 subjects randomized to either EDP-494 or placebo in a 3 to 1 ratio, with the exception of the food effect cohort, which will consist of 10 subjects randomised in a 4 to 1 ratio.
- Conditions
- Hepatitis C
- Being tested
- EDP-494, Placebo
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP-494Drug
10, 100 and 200 mg capsules
PlaceboDrug
placebo to match EDP-494
| Study group | Role | What they receive |
|---|---|---|
| EDP-494 SAD Cohorts | Experimental | EDP-494, oral 50 mg, 100mg, 200mg, 400mg and 800 mg, capsules, once daily in one single administration Receives: Drug: EDP-494 |
| EDP-494 MAD/POC Cohorts | Experimental | EDP-494, oral 200mg, 400mg and 800 mg, capsules, once daily for 14 days Receives: Drug: EDP-494 |
| EDP-494 SAD Placebo Cohort | Placebo comparator | Not described Receives: Drug: Placebo |
| EDP-494 MAD/POC Placebo Cohort | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, and abnormal clinical laboratory results administered to healthy volunteers and multiple doses of EDP-494
Tabulation of the number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results (including chemistry, hematology, and urine).
Administered to healthy volunteers and multiple doses of EDP-494 administered to healthy volunteers and subjects with Chronic Hepatitis C (CHC) genotype 1 and 3 infection
Measured: From screening and baseline to the 4 week follow-up visit
Secondary outcomes (6)
Cmax
EDP-494 and metabolites
Measured: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72 (Day 4), 96 (Day 5), 120 (Day 6)*, 144 (Day 7) and 168 (Day 8) hrs postdose
Cmax
EDP-494 and metabolites
Measured: Day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 5, 7, 9, 12: 0 (Predose); Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72, 96, 120, 144 and 168 hrs postdose
AUC
EDP-494 and metabolites
Measured: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72, 96, 120*, 144, and 168 hrs postdose
AUC
EDP-494 and metabolites
Measured: Day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 5, 7, 9, 12: 0 (Predose);Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72, 96, 120, 144 and 168 hrs postdose
Change from baseline in plasma HCV RNA (log10 IU/mL)
Measured: Baseline up to 14 days
Amino Acid Changes in HCV polymerase NS5b
Measured: Baseline up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study start10 Jan 2016
- Primary completion27 Dec 2016
- Study completion27 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Edward Gane, MD, Principal investigator, Auckland Clinical Studies (ACS),
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652377
- Sponsor's protocol ID
- EDP-494-001
- Status last verified
- Jan 2017
- First submitted
- 6 Jan 2016
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Once the clinical study report has been submitted to the appropriate Regulatory authorities, a lay person summary will be provided to all study subjects by mail or email.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Pbo-Controlled, Study of EDP-494 to Evaluate the Safety and PK of SAD/FE in Healthy Subjects and MAD in Healthy and in Subjects With CHC Infection (POC)
- ClinicalTrials.gov ID
- NCT02652377
- Acronym / sponsor ID
- EDP-494-001
- Conditions
- Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 27 Dec 2016 (actual)
- Study completion
- 27 Dec 2016 (actual)
- First posted
- 11 Jan 2016 (estimated)
- 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 randomized, double-blind study will assess the safety, pharmacokinetics and efficacy of a single and multiple dose(s) of orally QD administered EDP-494 in healthy volunteers (HV) and in treatment-naive subjects with GT1/3 chronic hepatitis C (CHC) infection.
Detailed description
The first phase explores single ascending doses of EDP-494 (active drug or placebo) in healthy subjects. A 'fasted' vs 'fed' two-part cohort will also assess food effect.
The second phase involves multiple ascending doses (active drug or placebo) for 14 days in healthy subjects.
The third, proof of concept, phase will assess two different doses for 14 days each in Hepatitis C patients.
Each cohort within each phase will consist of 8 subjects randomized to either EDP-494 or placebo in a 3 to 1 ratio, with the exception of the food effect cohort, which will consist of 10 subjects randomised in a 4 to 1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EDP-494 SAD Cohorts | Experimental | Drug: EDP-494EDP-494, oral 50 mg, 100mg, 200mg, 400mg and 800 mg, capsules, once daily in one single administration |
| EDP-494 MAD/POC Cohorts | Experimental | Drug: EDP-494EDP-494, oral 200mg, 400mg and 800 mg, capsules, once daily for 14 days |
| EDP-494 SAD Placebo Cohort | Placebo comparator | Drug: Placebo |
| EDP-494 MAD/POC Placebo Cohort | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females aged 18 years and less than 70 years.
- Female subjects must be of non-childbearing potential.
- All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug.
- Body mass index of 18 to 36 kg/m2 with a minimum body weight of 50 kg.
- Treatment naïve subjects with chronic HCV infection,
Key exclusion criteria (21 listed)
- Women of childbearing potential (WOCBP).
- Pregnant or nursing females.
- History of febrile illness within 7 days prior to the first dose of study drug.
- A positive urine drug screen at screening unless on an approved prescription.
- History of participation in a clinical trial with a polymerase inhibitor or previous treatment with a polymerase inhibitor, where at least one dose of the polymerase inhibitor was consumed. Subjects who were dosed with placebo on a clinical trial may be enrolled in this study.
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-49410, 100 and 200 mg capsules | Drug | EDP-494 MAD/POC Cohorts, EDP-494 SAD Cohorts |
| Placeboplacebo to match EDP-494 | Drug | EDP-494 MAD/POC Placebo Cohort, EDP-494 SAD Placebo Cohort |
Primary outcome
Composite number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, and abnormal clinical laboratory results administered to healthy volunteers and multiple doses of EDP-494
Time frame: From screening and baseline to the 4 week follow-up visit
Tabulation of the number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results (including chemistry, hematology, and urine). Administered to healthy volunteers and multiple doses of EDP-494 administered to healthy volunteers and subjects with Chronic Hepatitis C (CHC) genotype 1 and 3 infection
6 secondary outcomes
Cmax
Time frame: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72 (Day 4), 96 (Day 5), 120 (Day 6)*, 144 (Day 7) and 168 (Day 8) hrs postdose
Cmax
Time frame: Day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 5, 7, 9, 12: 0 (Predose); Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72, 96, 120, 144 and 168 hrs postdose
AUC
Time frame: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72, 96, 120*, 144, and 168 hrs postdose
AUC
Time frame: Day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 5, 7, 9, 12: 0 (Predose);Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72, 96, 120, 144 and 168 hrs postdose
Change from baseline in plasma HCV RNA (log10 IU/mL)
Time frame: Baseline up to 14 days
Amino Acid Changes in HCV polymerase NS5b
Time frame: Baseline up to 3 months
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 23 Jan 2017.
- Individual participant dataSharing planned: No. Once the clinical study report has been submitted to the appropriate Regulatory authorities, a lay person summary will be provided to all study subjects by mail or email.
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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.
Edward Gane, MD principal investigator
Auckland Clinical Studies (ACS),
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-494 in people with Hepatitis C, run by Enanta Pharmaceuticals, Inc at 1 site in New Zealand.
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 21 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 23 Jan 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 New Zealand. 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?
Composite number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, and abnormal clinical laboratory results administered to healthy volunteers and multiple doses of EDP-494 (time frame: From screening and baseline to the 4 week follow-up visit). 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 23 Jan 2017.