Presumptive NAFLDPhase 1NCT02918929
A Study of EDP 305 in Healthy Subjects and Subjects With Presumptive NAFLD
A Phase 1 study testing EDP 305 in people with Presumptive NAFLD, run by Enanta Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-305 in healthy adult subjects, and adult subjects with presumptive NAFLD (i.e., obese subjects with or without prediabetes or T2DM). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Presumptive NAFLD
- What is being tested?
- EDP 305
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Jun 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.
- 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.
- For healthy volunteers only (see below for Subjects with presumptive NAFLD): Body mass index of 18 to 30 kg/m2 with a minimum body weight of 50 kg.
- Additional Inclusion Criteria for MAD Subjects with Presumptive NAFLD:
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- Body mass index of >28 and <35 kg/m2 at screening.
- WITH or WITHOUT one of the following:
- Type 2 diabetes mellitus diagnosed by one of the following methods:
- As defined by the American Diabetes Association (ADA), as one of the following criteria: a) symptoms of diabetes plus casual plasma glucose concentration >200 mg/dL (11.1 mmol/L) OR b) Fasting plasma glucose >126 mg/dL (7.0 mmol/L) OR c) 2-hour post-load glucose >200 mg/dL (11.1 mmol/L) during a 75 g oGTT.
- HbA1c of at least 6.5%. --- OR---
- Prediabetes diagnosed as defined by the ADA as a) an HbA1c of 5.7% - 6.4% OR b) fasting blood glucose of 100-125 mg/dL OR c) an oGTT 2-hour blood glucose of 140 mg/dL - 199 mg/dL.
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 study drug administration.
- Use of prescription drugs, non-prescription drugs, dietary supplements including Vitamin E herbal supplements, hormonal therapy/replacement or CYP3A4 substrates, inducers and inhibitors within 14 days prior to the first dose of study medication.
- Additional Exclusion Criteria for MAD Subjects with Presumptive NAFLD:
- Subjects taking any antidiabetic medication.
- Subjects with unstable proliferative retinopathy, macular oedema (fundus examination performed in the previous year will be considered relevant on Investigator's judgement).
- Subject has taken fibrates, statins, and/or Vitamin E within 6 weeks prior to the first dose administration.
- Subjects with a history of bariatric surgery and any other gastrointestinal surgery relative to weight loss.
- Subjects with common causes of secondary hepatic steatosis.
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 Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-305 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD) and the Effect of Food on EDP-305 Pharmacokinetics in Healthy Subjects, and of Multiple Ascending Doses (MAD) in Subjects With Presumptive NAFLD
This randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-305 in healthy adult subjects, and adult subjects with presumptive NAFLD (i.e., obese subjects with or without prediabetes or T2DM).
Read the detailed description
The first phase assesses single ascending doses for EDP 305 (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 and also in subjects with presumptive NAFLD (i.e., obese subjects with or without prediabetes or T2DM).
Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-305 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-305 or placebo.
- Conditions
- Presumptive NAFLD
- Being tested
- EDP 305, Placebo
- Keywords
- First-in-human, Single Ascending Dose, Multiple Ascending Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP 305Drug
PlaceboDrug
placebo to match EDP 305
| Study group | Role | What they receive |
|---|---|---|
| EDP 305 SAD Cohorts | Experimental | EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration Receives: Drug: EDP 305 |
| EDP 305 MAD Cohorts | Experimental | EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral suspension, once daily for 14 days Receives: Drug: EDP 305 |
| EDP 305 SAD Placebo Cohort | Placebo comparator | Matching placebo, oral suspension, once daily in one single administration Receives: Drug: Placebo |
| EDP 305 MAD Placebo Cohort | Placebo comparator | Matching placebo, oral suspension, once daily for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety data including but not limited to adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urinalysis).
Measured: From screening to the 7-day post treatment safety follow up visit.
Secondary outcomes (4)
Cmax
EDP 305
Measured: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72 (D4), and 96 (D5) hrs post dose.
Cmax
EDP 305
Measured: Day 1: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 4, 5, 7, 9, 12; Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24 (D15), 30, 36, 48 (D16), 60, 72 (D17), and 96 (D18) hrs postdose
AUC
EDP 305
Measured: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, 72 (D4), and 96 (D5) hrs post dose.
AUC
EDP 305
Measured: Day 1: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 4, 5, 7, 9, 12; Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24 (D15), 30, 36, 48 (D16), 60, 72 (D17), and 96 (D18) hrs postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Presumptive NAFLDStudies 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates
- Responsible party
- Sponsor
- Investigators
- Daniel Dickerson, MD, Principal investigator, Pharmaceutical Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918929
- Sponsor's protocol ID
- EDP 305-001
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: When 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 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-305 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD) and the Effect of Food on EDP-305 Pharmacokinetics in Healthy Subjects, and of Multiple Ascending Doses (MAD) in Subjects With Presumptive NAFLD
- ClinicalTrials.gov ID
- NCT02918929
- Acronym / sponsor ID
- EDP 305-001
- Conditions
- Presumptive NAFLD
- Keywords
- First-in-human, Single Ascending Dose, Multiple Ascending Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates
- Study start
- Sep 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 29 Sep 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, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-305 in healthy adult subjects, and adult subjects with presumptive NAFLD (i.e., obese subjects with or without prediabetes or T2DM).
Detailed description
The first phase assesses single ascending doses for EDP 305 (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 and also in subjects with presumptive NAFLD (i.e., obese subjects with or without prediabetes or T2DM).
Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-305 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-305 or placebo.
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 305 SAD Cohorts | Experimental | Drug: EDP 305EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration |
| EDP 305 MAD Cohorts | Experimental | Drug: EDP 305EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral suspension, once daily for 14 days |
| EDP 305 SAD Placebo Cohort | Placebo comparator | Drug: PlaceboMatching placebo, oral suspension, once daily in one single administration |
| EDP 305 MAD Placebo Cohort | Placebo comparator | Drug: PlaceboMatching placebo, oral suspension, once daily for 14 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 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.
- 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.
- For healthy volunteers only (see below for Subjects with presumptive NAFLD): Body mass index of 18 to 30 kg/m2 with a minimum body weight of 50 kg.
Key exclusion criteria (15 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 305 | Drug | EDP 305 MAD Cohorts, EDP 305 SAD Cohorts |
| Placeboplacebo to match EDP 305 | Drug | EDP 305 MAD Placebo Cohort, EDP 305 SAD Placebo Cohort |
Primary outcome
Safety data including but not limited to adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urinalysis).
Time frame: From screening to the 7-day post treatment safety follow up visit.
4 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 (D4), and 96 (D5) hrs post dose.
Cmax
Time frame: Day 1: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 4, 5, 7, 9, 12; Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24 (D15), 30, 36, 48 (D16), 60, 72 (D17), and 96 (D18) 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 (D4), and 96 (D5) hrs post dose.
AUC
Time frame: Day 1: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 4, 5, 7, 9, 12; Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24 (D15), 30, 36, 48 (D16), 60, 72 (D17), and 96 (D18) hrs postdose
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 21 Aug 2017.
- Individual participant dataSharing planned: No. When 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.
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.
Daniel Dickerson, MD principal investigator
Pharmaceutical Research Associates
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 305 in people with Presumptive NAFLD, 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 12 inclusion and 15 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 21 Aug 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. 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 data including but not limited to adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urinalysis). (time frame: From screening to the 7-day post treatment safety 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 21 Aug 2017.