NASH - Nonalcoholic Steatohepatitis With Liver FibrosisPhase 1NCT04559126
A Study of EDP-297 in Healthy Subjects
A Phase 1 study testing EDP-297 in people with NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis, run by Enanta Pharmaceuticals, Inc at 1 site in Netherlands.
Trial summary
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis
- What is being tested?
- EDP-297
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Sep 2020to 21 Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 65 years, inclusive.
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 -2.
- Current tobacco smokers or use of tobacco within 1 months prior to screening.
- Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
- History of regular alcohol consumption exceeding 14 drinks/week for females and 21 drinks/week for males within 6 months of Screening.
- 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.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-297 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD), and the Effect of Food on EDP-297 Pharmacokinetics in Healthy Subjects
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.
Read the detailed description
The first phase assesses single ascending doses of EDP-297 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.
The second phase assesses multiple ascending doses of EDP-297 or placebo for 14-days in healthy subjects.
Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-297 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-297 or placebo
- Being tested
- EDP-297, Placebo
- Keywords
- "First-in-Human", Single Ascending Dose, Multiple Ascending Dose, Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP-297Drug
EDP-297 Oral solution
PlaceboDrug
placebo to match EDP-297
| Study group | Role | What they receive |
|---|---|---|
| EDP-297 SAD Cohorts | Experimental | EDP-297 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral solution, once daily in one single administration Receives: Drug: EDP-297 |
| EDP-297 MAD Cohorts | Experimental | EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days Receives: Drug: EDP-297 |
| EDP-297 SAD Placebo Cohort | Placebo comparator | Matching placebo, oral solution, once daily in one single administration Receives: Drug: Placebo |
| EDP-297 MAD Placebo Cohort | Placebo comparator | Matching placebo, oral solution, 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 measured by adverse events
Measured: Up to 8 Days in SAD Cohorts
Safety measured by adverse events
Measured: Up to 21 Days in MAD Cohorts
Secondary outcomes (4)
Cmax of EDP-297
Measured: Up to 6 Days in SAD Cohorts
Cmax of EDP-297
Measured: Up to 18 Days in MAD Cohorts
AUC of EDP-297
Measured: Up to 6 Days in SAD Cohorts
AUC of EDP-297
Measured: Up to 18 Days in MAD Cohorts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start8 Sep 2020
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NASH - Nonalcoholic Steatohepatitis With Liver FibrosisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 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
- NCT04559126
- Sponsor's protocol ID
- EDP 297-001
- Status last verified
- Oct 2021
- First submitted
- 10 Sep 2020
- Last updated
- 29 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marotta C, Ahmad A, Luo E, Oosterhaven J, van Marle S, Adda N. EDP-297: A novel, farnesoid X receptor agonist-Results of a phase I study in healthy subjects. Clin Transl Sci. 2023 Feb;16(2):338-351. doi: 10.1111/cts.13453. Epub 2022 Nov 21.
PubMed 36369848
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. 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-297 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD), and the Effect of Food on EDP-297 Pharmacokinetics in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04559126
- Acronym / sponsor ID
- EDP 297-001
- Keywords
- "First-in-Human", Single Ascending Dose, Multiple Ascending Dose, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 22 Sep 2020 (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 study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.
Detailed description
The first phase assesses single ascending doses of EDP-297 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.
The second phase assesses multiple ascending doses of EDP-297 or placebo for 14-days in healthy subjects.
Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-297 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-297 or placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EDP-297 SAD Cohorts | Experimental | Drug: EDP-297EDP-297 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral solution, once daily in one single administration |
| EDP-297 MAD Cohorts | Experimental | Drug: EDP-297EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days |
| EDP-297 SAD Placebo Cohort | Placebo comparator | Drug: PlaceboMatching placebo, oral solution, once daily in one single administration |
| EDP-297 MAD Placebo Cohort | Placebo comparator | Drug: PlaceboMatching placebo, oral solution, once daily for 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 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 65 years, inclusive.
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 -2.
- Current tobacco smokers or use of tobacco within 1 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-297EDP-297 Oral solution | Drug | EDP-297 MAD Cohorts, EDP-297 SAD Cohorts |
| Placeboplacebo to match EDP-297 | Drug | EDP-297 MAD Placebo Cohort, EDP-297 SAD Placebo Cohort |
Primary outcome
Safety measured by adverse events
Time frame: Up to 8 Days in SAD Cohorts
Safety measured by adverse events
Time frame: Up to 21 Days in MAD Cohorts
4 secondary outcomes
Cmax of EDP-297
Time frame: Up to 6 Days in SAD Cohorts
Cmax of EDP-297
Time frame: Up to 18 Days in MAD Cohorts
AUC of EDP-297
Time frame: Up to 6 Days in SAD Cohorts
AUC of EDP-297
Time frame: Up to 18 Days in MAD Cohorts
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 29 Oct 2021.
- Derived from this study: PubMed 36369848Marotta C, Ahmad A, Luo E, Oosterhaven J, van Marle S, Adda N. EDP-297: A novel, farnesoid X receptor agonist-Results of a phase I study in healthy subjects. Clin Transl Sci. 2023 Feb;16(2):338-351. doi: 10.1111/cts.13453. Epub 2022 Nov 21.
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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-297 in people with NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis, run by Enanta Pharmaceuticals, Inc at 1 site in Netherlands.
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 2 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 29 Oct 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 Netherlands. 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 measured by adverse events (time frame: Up to 8 Days in SAD Cohorts). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04559126, which also lists 1 linked publication.
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 29 Oct 2021.