Non-alcoholic SteatohepatitisPhase 1NCT05835180
A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
A Phase 1 study testing TVB-2640 - 50 mg in people with Non-alcoholic Steatohepatitis and Hepatic Impairment, run by Sagimet Biosciences Inc. at 3 sites in 2 countries.
Trial summary
The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis
- What is being tested?
- TVB-2640 - 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 May 2023to 18 Dec 2023
- 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
- Subjects must satisfy all of the following criteria at the Screening visit unless otherwise stated:
- All Subjects
- Males or females, of any race, between 18 and 75 years of age, inclusive.
- Body mass index between 18.0 and 42.0/45.0 kg/m2 (inclusive; up to 42.0 kg/m2 for subjects without ascites and 45.0 kg/m2 for subjects with ascites)
- Females will not be pregnant or lactating, and females of childbearing potential (premenopausal females who are anatomically and physiologically capable of becoming pregnant following menarche) and males will agree to use contraception as detailed in the protocol.
- Subjects with Hepatic Impairment Only
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- Documented chronic stable liver disease; diagnosis of cirrhosis due to parenchymal liver disease. T
- Subjects with mild, moderate, or severe hepatic impairment may have medical findings consistent with their hepatic dysfunction.
- Non-hepatic, abnormal clinical laboratory evaluations must not be clinically relevant.
- Currently on a stable medication regimen; Concomitant medications administered within 30 days prior to the first dose administration (Day 1) must be approved by the Investigator (or designee), Sponsor, and the Medical Monitor.
- Anemia secondary to hepatic disease will be acceptable if hemoglobin > 9 g/dL and anemia symptoms are not clinically significant as judged by the Investigator (or designee) and the Medical Monitor. Subjects must have a platelet count ≥ 35 × 109 platelets/L for mild and moderate hepatic impairment subjects and ≥ 30 × 109 platelets/L for severe hepatic impairment subjects.
- Subjects with diabetes mellitus may be included, provided the subjects have:
- Hemoglobin A1c values ≤ 9.0% at Screening. Subjects with values outside this range may be allowed by the Medical Monitor on a case-by-case basis.
- Medications for the treatment of diabetes mellitus must be reviewed and approved by the Investigator (or designee), Medical Monitor, and Sponsor.
Who cannot join
- Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:
- All Subjects
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of corneal edema, keratitis, xerophthalmia (dry eye), or other corneal abnormalities. Subjects may wear contact lenses during the study with the exception of the day of dosing (Days 1 to Day 4).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except uncomplicated appendectomy, hernia repair, and cholecystectomy will be allowed; bariatric surgery will not be allowed).
- Ventricular dysfunction or history of risk factors for Torsade de Pointes. Subjects will be excluded if there is a family history of long QT syndrome.
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- Evidence of hepatorenal syndrome and Cockcroft-Gault estimated creatinine clearance (CrCl) ≤ 60 mL/min/1.73 m2 for mild and moderate hepatic impairment subjects, ≤ 50 mL/min/1.73 m2 for severe hepatic impairment subjects or clinically significant abnormal sodium and potassium levels, as determined by the Investigator (or designee), at Screening or Check-in (Day 1).
- Use or intended use of any medications/products known to alter drug absorption, metabolism, or elimination processes.
- Use of any strong inhibitors or inducers of cytochrome P450 (CYP)2C9 or CYP3A4/5, or inhibitors of CYP3A4 within 30 days prior to first dose administration (Day 1).
- Alcohol consumption of > 21 units per week for males and > 14 units for females.
- Positive urine drug screen
- Positive severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) polymerase chain reaction (PCR) test at Screening and Check-in (Day -1), history of hospitalization for coronavirus disease-2019 (COVID-19), or history of use of oxygen due to COVID-19. Note that previous COVID-19 infection alone is not exclusionary and vaccination against SARS-CoV-2 is allowed but must be documented.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Thomas C. Marbury
Orlando, Florida, 32809
Eric J. Lawitz, MD
San Antonio, Texas, 78215
About this study
Official title: A Phase I, Open-label, Pharmacokinetic Study of TVB-2640 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function.
- Conditions
- Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis
- Being tested
- TVB-2640 - 50 mg
- Keywords
- NASH, Hepatic impairment, Cirrhosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVB-2640 - 50 mgDrug
TVB-2640 -50 mg administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| TVB-2640 50 mg - normal hepatic function | Experimental | Healthy subjects with normal hepatic function receive 50 mg PO daily from Day 1 to Day 4 Receives: Drug: TVB-2640 - 50 mg |
| TVB-2640 50 mg - mild hepatic function | Experimental | Subjects with mild hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4 Receives: Drug: TVB-2640 - 50 mg |
| TVB-2640 50 mg - moderate hepatic function | Experimental | Subjects with moderate hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4 Receives: Drug: TVB-2640 - 50 mg |
| TVB-2640 50 mg - severe hepatic function | Experimental | Subjects with severe hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4 Receives: Drug: TVB-2640 - 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total TVB-2640 plasma concentration-time (AUC) at steady state
Total TVB-2640 plasma concentration-time curve during a dosing interval at steady-state
Measured: Day 4
Unbound TVB-2640 plasma concentration-time (AUC) at steady state
Unbound TVB-2640 plasma concentration-time curve during a dosing interval at steady-state
Measured: Day 4
Maximum plasma concentration (Cmax) for total TVB-2640 at steady state
Measured: Day 4
Maximum plasma concentration (Cmax) for unbound TVB-2640 at steady state
Measured: Day 4
incidence and severity of AEs
Measured: Screening to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 May 2023
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sagimet Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835180
- Sponsor's protocol ID
- SB2640-CLIN-009
- Status last verified
- Dec 2023
- First submitted
- 17 Apr 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Pharmacokinetic Study of TVB-2640 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT05835180
- Acronym / sponsor ID
- SB2640-CLIN-009
- Conditions
- Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis
- Keywords
- NASH, Hepatic impairment, Cirrhosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sagimet Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 28 Apr 2023 (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.
The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TVB-2640 50 mg - normal hepatic function | Experimental | Drug: TVB-2640 - 50 mgHealthy subjects with normal hepatic function receive 50 mg PO daily from Day 1 to Day 4 |
| TVB-2640 50 mg - mild hepatic function | Experimental | Drug: TVB-2640 - 50 mgSubjects with mild hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4 |
| TVB-2640 50 mg - moderate hepatic function | Experimental | Drug: TVB-2640 - 50 mgSubjects with moderate hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4 |
| TVB-2640 50 mg - severe hepatic function | Experimental | Drug: TVB-2640 - 50 mgSubjects with severe hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must satisfy all of the following criteria at the Screening visit unless otherwise stated:
- All Subjects
- Males or females, of any race, between 18 and 75 years of age, inclusive.
- Body mass index between 18.0 and 42.0/45.0 kg/m2 (inclusive; up to 42.0 kg/m2 for subjects without ascites and 45.0 kg/m2 for subjects with ascites)
- Females will not be pregnant or lactating, and females of childbearing potential (premenopausal females who are anatomically and physiologically capable of becoming pregnant following menarche) and males will agree to use contraception as detailed in the protocol.
Key exclusion criteria (12 listed)
- Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:
- All Subjects
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of corneal edema, keratitis, xerophthalmia (dry eye), or other corneal abnormalities. Subjects may wear contact lenses during the study with the exception of the day of dosing (Days 1 to Day 4).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except uncomplicated appendectomy, hernia repair, and cholecystectomy will be allowed; bariatric surgery will not be allowed).
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 |
|---|---|---|
| TVB-2640 - 50 mgTVB-2640 -50 mg administered orally once daily | Drug | TVB-2640 50 mg - mild hepatic function, TVB-2640 50 mg - moderate hepatic function, TVB-2640 50 mg - normal hepatic function, TVB-2640 50 mg - severe hepatic function |
Primary outcome
Total TVB-2640 plasma concentration-time (AUC) at steady state
Time frame: Day 4
Total TVB-2640 plasma concentration-time curve during a dosing interval at steady-state
Unbound TVB-2640 plasma concentration-time (AUC) at steady state
Time frame: Day 4
Unbound TVB-2640 plasma concentration-time curve during a dosing interval at steady-state
Maximum plasma concentration (Cmax) for total TVB-2640 at steady state
Time frame: Day 4
Maximum plasma concentration (Cmax) for unbound TVB-2640 at steady state
Time frame: Day 4
incidence and severity of AEs
Time frame: Screening to Day 7
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 26 Dec 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TVB-2640 - 50 mg in people with Non-alcoholic Steatohepatitis and Hepatic Impairment, run by Sagimet Biosciences Inc. at 3 sites in 2 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 14 inclusion and 12 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 26 Dec 2023. 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, Hungary. 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?
Total TVB-2640 plasma concentration-time (AUC) at steady state (time frame: Day 4). The study lists 5 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 26 Dec 2023.