NASHPhase 1NCT03207425
A Study of EDP-305 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
A Phase 1 study testing EDP 305 in people with NASH, run by Enanta Pharmaceuticals, Inc at 3 sites in 3 countries.
Trial summary
This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to matched healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- NASH
- What is being tested?
- EDP 305
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 14 Jun 2017to 19 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand and willing to sign the ICF and able to comply with the study restrictions
- Adult male or female subjects age 18 to 75 years, inclusive, at the time of informed consent
- Female subjects must be non-childbearing potential
- Additional criteria for hepatically impaired subjects
- Confirmed diagnosis of cirrhosis due to parenchymal liver disease
- Stable hepatic impairment, defined as no clinically significant change in disease status, as judged by the Investigator
Who cannot join
- Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at Screening that the Investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer except for conditions associated with hepatic impairment in subjects with compromised hepatic function
- Clinically significant renal disease
- Additional criteria for hepatically impaired Subjects
- History of esophageal bleeding within the last 3 months prior to study drug administration
- Severe hepatic encephalopathy (Grade >2) or degree of central nervous system (CNS) impairment
- History of liver transplantation
Show all 13Show fewer
- Presence of Hepatocellular Carcinoma, or suspicion of Hepatocellular Carcinoma based on Investigator's judgment
- Hepato-renal or hepato-pulmonary syndrome
- Prior placement of a portosystemic shunt
- Spontaneous bacterial peritonitis currently or within the last 6 months
- Hospitalization within the last 2 months related to cirrhosis
- Advanced ascites and ascites which require emptying and albumin supplementation, as judged by the Investigator
- Hemoglobin concentration < 10.0 g/dL
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
American Research Corporation at The Texas Liver Institute
San Antonio, Texas, 78215
About this study
Official title: A Phase 1, Open-Label, Parallel Group, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of EDP 305 in Subjects With Varying Degrees of Hepatic Function
This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to matched healthy subjects.
- Conditions
- NASH
- Being tested
- EDP 305
- Keywords
- Hepatic Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP 305Drug
Each subject will receive a single dose of EDP 305 on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic impairment group | Experimental | Not described Receives: Drug: EDP 305 |
| Moderate hepatic impairment group | Experimental | Not described Receives: Drug: EDP 305 |
| Matching healthy control group | Experimental | Healthy control group will be matched with the hepatically impaired population with respect to age, sex and BMI 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
Measured: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
AUCinf of EDP 305
Measured: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
t1/2 of EDP 305
Measured: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
CL/F of EDP 305
Measured: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
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: From Screening up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start14 Jun 2017
- Primary completion16 Sep 2017
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASHStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 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
- NCT03207425
- Sponsor's protocol ID
- EDP 305-003
- Status last verified
- Jun 2017
- First submitted
- 30 Jun 2017
- Last updated
- 6 Nov 2017
- Results posted
- 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 Phase 1, Open-Label, Parallel Group, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of EDP 305 in Subjects With Varying Degrees of Hepatic Function
- ClinicalTrials.gov ID
- NCT03207425
- Acronym / sponsor ID
- EDP 305-003
- Conditions
- NASH
- Keywords
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 16 Sep 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 2 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 study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to matched healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild hepatic impairment group | Experimental | Drug: EDP 305 |
| Moderate hepatic impairment group | Experimental | Drug: EDP 305 |
| Matching healthy control group | Experimental | Drug: EDP 305Healthy control group will be matched with the hepatically impaired population with respect to age, sex and BMI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to understand and willing to sign the ICF and able to comply with the study restrictions
- Adult male or female subjects age 18 to 75 years, inclusive, at the time of informed consent
- Female subjects must be non-childbearing potential
- Additional criteria for hepatically impaired subjects
- Confirmed diagnosis of cirrhosis due to parenchymal liver disease
Key exclusion criteria (13 listed)
- Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at Screening that the Investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer except for conditions associated with hepatic impairment in subjects with compromised hepatic function
- Clinically significant renal disease
- Additional criteria for hepatically impaired Subjects
- History of esophageal bleeding within the last 3 months prior to study drug administration
- Severe hepatic encephalopathy (Grade >2) or degree of central nervous system (CNS) impairment
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 305Each subject will receive a single dose of EDP 305 on Day 1. | Drug | Matching healthy control group, Mild hepatic impairment group, Moderate hepatic impairment group |
Primary outcome
Cmax of EDP 305
Time frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
AUCinf of EDP 305
Time frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
t1/2 of EDP 305
Time frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
CL/F of EDP 305
Time frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
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: From Screening up to Day 14
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, Inc
3 sites in 3 countries: 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, run by Enanta Pharmaceuticals, Inc at 3 sites in 3 countries.
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 6 inclusion and 13 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 3 sites in United States, Czechia, Slovakia. 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 (time frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)). 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.