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Pharmacokinetic Study of Oral TVB-2640 in Adults with Mild, Moderate, or Severe Hepatic Impairment and in Healthy Volunteers

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What is this study about?

The study focuses on people who have hepatic impairment, a condition where the liver does not work as well as it should. The severity can range from mild, where the liver is only slightly affected, to moderate or severe, where the liver’s ability to process substances is greatly reduced. The investigational medication being examined is taken by mouth as a tablet and is identified by the code name TVB-2640. This drug is being tested to understand how it behaves in the bodies of individuals with different levels of liver function.

The main goal of the research is to assess the pharmacokinetics of the medication, which means learning how the drug is absorbed, distributed, broken down, and cleared from the body. Participants will receive the tablet once daily for several days, and during this time they will have blood samples drawn to measure the amount of drug present. Additional safety checks such as routine lab tests, heart rhythm recordings, and vital sign measurements will be performed to monitor how well participants tolerate the medication.

1 baseline visit

after joining the study, you will attend a baseline visit where your health status is checked. this includes measurements of vital signs, a physical examination, and laboratory tests such as blood work and urine analysis. the purpose is to confirm eligibility and record your normal hepatic function or level of impairment.

2 first dose of <b>tvb-2640</b>

on day 1 you will take one 50 mg oral tablet of tvb-2640. the tablet is swallowed with a glass of water and can be taken with or without food unless instructed otherwise.

shortly after the dose, blood samples will be drawn at several time points during the next 24 hours. these samples are used to measure how the drug is absorbed, distributed, and eliminated from your body (pharmacokinetics).

3 daily dosing days 2 to 4

you will continue to take the same 50 mg oral tablet each morning for three more days (day 2, day 3, and day 4). the dose is taken once daily at approximately the same time each day.

each day, vital signs and safety assessments such as electrocardiograms and laboratory tests may be performed to monitor any adverse effects.

4 steady‑state sampling on day 4

on day 4, after the dose has reached steady state (meaning the drug level in your blood has become stable), additional blood samples will be collected. these samples are used to calculate primary pharmacokinetic parameters such as the area under the concentration‑time curve (auc) and the maximum concentration (cmax) at steady state.

the same safety measurements performed on previous days will be repeated to ensure continued monitoring.

5 final safety evaluation

after the last dose and sampling on day 4, a final safety evaluation is performed. this includes a complete set of laboratory tests, a physical examination, and a review of any adverse events that may have occurred during the study.

the study team will document the results and inform you that the trial portion is completed.

Who Can Join the Study?

  • Be a man or a woman.
  • Be at least 18 years old and no older than 75 years.
  • Have a body mass index (a number that compares weight to height) of 18 or higher and not higher than 42; if you have fluid buildup in the abdomen called ascites, the maximum can be 45.
  • Be in generally good health, except for the specific liver condition being studied.
  • Fit into one of the study groups: a healthy volunteer with normal liver function, or a patient with mild, moderate, or severe hepatic impairment (reduced liver function).
  • Agree to take the study medication by mouth multiple times as instructed.

Who Cannot Join the Study?

  • Women who are pregnant (carrying a baby) or lactating (breast‑feeding) cannot take part in the study.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Cmv Hpcnpma Kxxm Encs Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Hungary Hungary
Not recruiting
07.07.2023

Trial locations

TVB-2640 is an experimental oral tablet being tested in this study. Researchers are giving it to people with different levels of liver function—mild, moderate, severe impairment, and normal—to see how the liver affects the drug’s absorption, distribution, and elimination. By measuring these pharmacokinetic properties, the trial aims to understand whether the drug can be safely and effectively used in patients whose liver does not work normally. This information will help decide appropriate dosing or identify any safety concerns for future use.

Impaired hepatic function – It is a condition in which the liver’s ability to filter blood, produce proteins, and metabolize substances is reduced. The severity is commonly classified as mild, moderate, or severe using the Child‑Pugh scoring system. In mild impairment, most liver activities remain near normal, while moderate impairment shows noticeable loss of function and laboratory changes. Severe impairment indicates a marked decline in synthetic and metabolic capacity, often leading to accumulation of waste products. The condition can remain stable for a period or gradually worsen if the underlying liver disease progresses.

Trial ID:
2023-505180-36-00
Protocol code:
SB2640-CLIN-009
Trial Phase:
Human Pharmacology (Phase I) – Other

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