NASH - Nonalcoholic SteatohepatitisPhase 1NCT03748628
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
A Phase 1 study testing EDP-305 in people with NASH - Nonalcoholic Steatohepatitis, run by Enanta Pharmaceuticals, Inc at 1 site in United States.
Trial summary
A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]EDP-305 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- EDP-305
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2018to 13 Oct 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 32.0 kg/m2 (inclusive)
- able to comprehend and willing to sign an Informed Consent Form
- In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (including gastrectomy and cholecystectomy; uncomplicated appendectomy and hernia repair will be allowed).
- Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]EDP-305 Following a Single Oral Dose in Healthy Male Subjects
A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]EDP-305 in healthy male subjects.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- EDP-305
- Keywords
- AME Study
- 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.
EDP-305Drug
[14C]EDP-305
| Study group | Role | What they receive |
|---|---|---|
| Single arm EDP-305 | Experimental | Not described Receives: Drug: EDP-305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of EDP-305 in plasma
Measured: Up to 9 days
AUC of EDP-305 in plasma
Measured: Up to 9 days
AUC-inf in plasma
Measured: Up to 9 days
Secondary outcomes (3)
Amount excreted in urine (Aeu)
Measured: Up to 9 days
Amount excreted in feces (Aef)
Measured: Up to 9 days
Safety measured by adverse events
Measured: Up to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start5 Oct 2018
- Primary completion13 Oct 2018
- Study completion13 Oct 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT03748628
- Sponsor's protocol ID
- EDP 305-009
- Status last verified
- Oct 2018
- First submitted
- 31 Oct 2018
- Last updated
- 21 Nov 2018
- 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 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]EDP-305 Following a Single Oral Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03748628
- Acronym / sponsor ID
- EDP 305-009
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Keywords
- AME Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 13 Oct 2018 (actual)
- Study completion
- 13 Oct 2018 (actual)
- First posted
- 21 Nov 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.
A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]EDP-305 in healthy male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm EDP-305 | Experimental | Drug: EDP-305 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 32.0 kg/m2 (inclusive)
- able to comprehend and willing to sign an Informed Consent Form
- In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations.
Key exclusion criteria (3 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (including gastrectomy and cholecystectomy; uncomplicated appendectomy and hernia repair will be allowed).
- Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks 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[14C]EDP-305 | Drug | Single arm EDP-305 |
Primary outcome
Cmax of EDP-305 in plasma
Time frame: Up to 9 days
AUC of EDP-305 in plasma
Time frame: Up to 9 days
AUC-inf in plasma
Time frame: Up to 9 days
3 secondary outcomes
Amount excreted in urine (Aeu)
Time frame: Up to 9 days
Amount excreted in feces (Aef)
Time frame: Up to 9 days
Safety measured by adverse events
Time frame: Up to 9 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 21 Nov 2018.
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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-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 3 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 Nov 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 in plasma (time frame: Up to 9 days). The study lists 3 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 21 Nov 2018.