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

Key Inclusion Criteria: Subjects must satisfy all of the following criteria at the Screening visit unless otherwisestated: 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 forsubjects 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 becomingpregnant following menarche) and males will agree to use contraception as detailed inthe protocol. Subjects with Hepatic Impairment Only
• Documented chronic stable liver disease; diagnosis of cirrhosis due to parenchymalliver disease. T
• Subjects with mild, moderate, or severe hepatic impairment may have medical findingsconsistent 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 theInvestigator (or designee), Sponsor, and the Medical Monitor.
• Anemia secondary to hepatic disease will be acceptable if hemoglobin > 9 g/dL andanemia symptoms are not clinically significant as judged by the Investigator (ordesignee) and the Medical Monitor. Subjects must have a platelet count ≥ 35 × 109platelets/L for mild and moderate hepatic impairment subjects and ≥ 30 × 109platelets/L for severe hepatic impairment subjects.
• Subjects with diabetes mellitus may be included, provided the subjects have:

1. Hemoglobin A1c values ≤ 9.0% at Screening. Subjects with values outside thisrange 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 theInvestigator (or designee), Medical Monitor, and Sponsor.

Key Exclusion Criteria: Subjects will be excluded from the study if they satisfy any of the following criteria atthe 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 theInvestigator (or designee).
• History of corneal edema, keratitis, xerophthalmia (dry eye), or other cornealabnormalities. Subjects may wear contact lenses during the study with the exception ofthe day of dosing (Days 1 to Day 4).
• History of stomach or intestinal surgery or resection that would potentially alterabsorption and/or excretion of orally administered drugs (except uncomplicatedappendectomy, hernia repair, and cholecystectomy will be allowed; bariatric surgerywill not be allowed).
• Ventricular dysfunction or history of risk factors for Torsade de Pointes. Subjectswill be excluded if there is a family history of long QT syndrome.
• Evidence of hepatorenal syndrome and Cockcroft-Gault estimated creatinine clearance (CrCl) ≤ 60 mL/min/1.73 m2 for mild and moderate hepatic impairment subjects, ≤ 50mL/min/1.73 m2 for severe hepatic impairment subjects or clinically significantabnormal 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, orinhibitors 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 chainreaction (PCR) test at Screening and Check-in (Day -1), history of hospitalization forcoronavirus disease-2019 (COVID-19), or history of use of oxygen due to COVID-19. Notethat previous COVID-19 infection alone is not exclusionary and vaccination againstSARS-CoV-2 is allowed but must be documented.