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Completed

NCT Number: NCT06093230

A Study in Subjects With Liver Function Injury and Subjects With Normal Liver Function

Evaluate the pharmacokinetic differences of the main metabolite 116-N1 of JT001 in subjects with mild and moderate liver function impairment and those with normal liver function, providing a basis for formulating clinical medication plans for patients with liver function impairment;

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Key information

Conditions

Subjects With Liver Function Injury Normal Liver Function Subject

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Hospital of Jilin University Ethics Committee

Changchun, Jilin, 130021, China

About this study

This study adopts a non randomized, open, parallel controlled, single dose experimental design and is divided into three experimental groups: mild liver function impairment group (Group A), moderate liver function impairment group (Group B), and normal liver function subject group (Group C). Subjects in each experimental group took 0.3g of JT001 orally on an empty stomach and collected blood samples before and after administration for pharmacokinetic analysis.

After both groups A and B were enrolled, Group C subjects will be enrolled subsequently and should be matched with subjects with liver function impairment (Group A and Group B) as following:

The average body weight of Group C is within ± 10 kg of the average body weight of the group of subjects with liver function impairment (Groups A and B).

The average age of Group C is within ± 10 years of the average age of the group of subjects with liver function impairment (Groups A and B).

The number of subjects of each gender in Group C is similar to that in the liver function impairment group (A and B groups) (± 1 subject/gender).

The study is divided into three stages: screening period, baseline period, and experimental period.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • On the day of signing the informed consent form, the age range is 18 to 70 years (including both ends), both male and female are eligible;
  • Male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; Body mass index (BMI) 18-32 kg/m2 (including both ends), where BMI=weight (kg)/height 2 (m2);

Subjects with normal liver function also need to meet all the following conditions:

  • When screening, the following demographic matching criteria must be met:
  • Match the weight with the liver function impairment group, with a mean of ± 10 kg;
  • Age matched with the liver function impairment group, with a mean of ± 10 years;
  • Gender matching was performed with the liver function impairment group, with a mean of ± 1 case;

Subjects with liver function impairment also need to meet all the following conditions:

  • Patients with chronic liver injury caused by primary liver diseases (such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.) and stable liver function (without any liver disease related medical records within 14 days before taking the study drug, except for regular follow-up and medication) with liver dysfunction classified as A or B by Child-Pugh ;
  • Clinically diagnosed as liver cirrhosis;
  • Those who have a stable medication plan for the treatment of liver function damage, complications, and other accompanying diseases for at least 14 days before taking the study drug, and the medication does not need to be adjusted (including medication type, dosage, or frequency); Or those who have not taken medication;
  • Estimated Glomerular filtration rate (eGFR, calculated using the CKD-EPI formula) ≥ 60 mL/min/1.73m2;

Exclusion criteria

  • The electrocardiogram shows a QTc interval (QTcF) of>450 msec for males and>470 msec for females (corrected according to Fridericia's standard);
  • Screening for individuals with severe infections, trauma, gastrointestinal surgery, or other major surgical procedures within the first 4 weeks;
  • Those who have received the vaccine within 14 days before screening or plan to receive the vaccine during the study period;
  • Those who donate blood or have a blood loss of ≥ 400 mL within the first 3 months of screening, or intend to donate blood during or within 1 month after the trial;
  • Screening for potent inhibitors or inducers of Pg-P or BCRP that have been used within the previous month (see Attachment 4);
  • Those who have taken a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice, and/or caffeinated beverages (an average of 8 or more cups per day, 200 mL per cup) within 2 weeks before administration;
  • Screening for alcoholics within the first three months, i.e. those who consume more than 14 units of alcohol per week (1 unit=360 mL of beer, or 45 mL of 40% alcohol or 150 mL of wine) or those who are positive for alcohol screening;
  • Individuals who smoke an average of 10 or more cigarettes per day within the first 3 months of screening;

Subjects with normal liver function who meet any of the following exclusion criteria need to be excluded:

  • History of liver injury;
  • Individuals who have previously or currently suffered from any clinical serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases that may interfere with the test results;
  • Abnormalities in physical examination, vital signs, laboratory examination, 12 lead electrocardiogram, abdominal ultrasound, and other examinations have been determined by the researcher to have clinical significance;
  • Those who are positive in any index screening of hepatitis B surface antigen, hepatitis C antibody or hepatitis C core antigen, HIV antigen/antibody or syphilis antibody;
  • Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or supplements within 14 days prior to the administration of the study drug;

Subjects with liver function impairment who meet any of the following exclusion criteria need to be excluded:

  • The subject has any of the following conditions: drug-induced liver injury; History of liver transplantation; And researchers believe that liver cirrhosis
  • During screening, the laboratory test results meet any of the following criteria: (a) alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>5 × ULN; (b) Absolute value of neutrophils (NE #)<1 × 109/L; (c) Hemoglobin (HGB)<80 g/L; (d) Alpha fetoprotein (AFP)>100 ng/mL;
  • Except for the primary liver disease itself, those who have previously or currently suffered from other serious organ system diseases, including but not limited to gastrointestinal, respiratory, renal, neurological, hematological, endocrine, tumor, immune, mental, or cardiovascular diseases or clinical laboratory examination abnormalities, which have clinical significance, and are determined by the research doctor to be unsuitable for participating in this trial;

Treatment and study plan

Deuremidevir Hydrobromide Tablets

Drug

JT001 single dose, 0.3g

Other names: JT001

Primary outcomes

  1. The Cmax of the main metabolite 116-N1 of JT001;

    Time frame: From time zero up to 72 hours post-dose following oral administration of JT001

    maximum observed plasma concentration

  2. The AUC0-t of the main metabolite 116-N1 of JT001;

    Time frame: From time zero up to 72 hours post-dose following oral administration of JT001

    area under the curve from time zero to the last measurable concentration

  3. The AUC0-inf of the main metabolite 116-N1 of JT001;

    Time frame: From time zero up to 72 hours post-dose following oral administration of JT001

    area under curve from time zero to infinity

  4. Tmax of the main metabolite 116-N1 of JT001;

    Time frame: From time zero up to 72 hours post-dose following oral administration of JT001

    Time to maximum observed concentration of the main metabolite 116-N1 of JT001;

  5. t1/2 of the main metabolite 116-N1 of JT001;

    Time frame: From time zero up to 72 hours post-dose following oral administration of JT001

    Terminal phase half-life of the main metabolite 116-N1 of JT001;

  6. CL/F of the main metabolite 116-N1 of JT001;

    Time frame: From time zero up to 72 hours post-dose following oral administration of JT001

    The clearance of the main metabolite 116-N1 of JT001;

  7. Vz/F of the main metabolite 116-N1 of JT001;

    Time frame: From time zero up to 72 hours post-dose following oral administration of JT001

    The apparent volume of distribution of the main metabolite 116-N1 of JT001;

  8. The severity of SAE

    Time frame: From Day 1(first dose) to Day7

    The severity of SAE

  9. The Number of participants with SAE

    Time frame: From Day 1(first dose) to Day7

    The Number of participants with SAE

  10. The severity ofclinical symptoms abnormalities(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）

    Time frame: From Day 1(first dose) to Day7

    The severity ofclinical symptoms abnormalities(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）

  11. The Number of participantswith abnormal clinical symptoms(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）

    Time frame: From Day 1(first dose) to Day7

    The Number of participantswith abnormal clinical symptoms(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）

  12. The severity of vital signs abnormalities

    Time frame: From Day 1(first dose) to Day7

    The severity of Pulse abnormalities

  13. The Number of participantswith abnormal vital signs

    Time frame: From Day 1(first dose) to Day7

    The Number of participantswith abnormal Pulse

  14. The severity of vital signs abnormalities

    Time frame: From Day 1(first dose) to Day7

    The severity of blood pressure abnormalities

  15. The Number of participantswith abnormal vital signs

    Time frame: From Day 1(first dose) to Day7

    The Number of participantswith abnormal blood pressure

  16. The severity of vital signs abnormalities

    Time frame: From Day 1(first dose) to Day7

    The severity of respiration abnormalities

  17. The Number of participantswith abnormal vital signs

    Time frame: From Day 1(first dose) to Day7

    The Number of participantswith abnormal respiration

  18. The severity of vital signs abnormalities

    Time frame: From Day 1(first dose) to Day7

    The severity of body temperature abnormalities

  19. The Number of participantswith abnormal vital signs

    Time frame: From Day 1(first dose) to Day7

    The Number of participantswith abnormal body temperature

  20. The severity of abnormal physical examinations findings

    Time frame: From Day 1(first dose) to Day7

    The severity of abnormal physical examinations findings

  21. The Number of participantswith abnormal physical examinations findings

    Time frame: From Day 1(first dose) to Day7

    The Number of participantswith abnormal physical examinations findings

  22. The severity of abnormal laboratory tests results

    Time frame: From Day 1(first dose) to Day7

    The severity of abnormal laboratory tests results

  23. The Number of participantswith abnormal laboratory tests results

    Time frame: From Day 1(first dose) to Day7

    The Number of participantswith abnormal laboratory tests results

  24. The severity of electrocardiogram (ECG) abnormalities

    Time frame: From Day 1(first dose) to Day7

    The severity of Heart rate abnormalities

  25. The Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: From Day 1(first dose) to Day7

    The Number of participants with Heart rate abnormalities

  26. The severity of electrocardiogram (ECG) abnormalities

    Time frame: From Day 1(first dose) to Day7

    The severity of PR interval abnormalities

  27. The Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: From Day 1(first dose) to Day7

    The Number of participants with PR interval abnormalities

  28. The severity of electrocardiogram (ECG) abnormalities

    Time frame: From Day 1(first dose) to Day7

    The severity of QRS interval abnormalities

  29. The Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: From Day 1(first dose) to Day7

    The Number of participants with QRS interval abnormalities

  30. The severity of electrocardiogram (ECG) abnormalities

    Time frame: From Day 1(first dose) to Day7

    The severity of QT interval abnormalities

  31. The Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: From Day 1(first dose) to Day7

    The Number of participants with QT interval abnormalities

  32. The severity of electrocardiogram (ECG) abnormalities

    Time frame: From Day 1(first dose) to Day7

    The severity of QTcF abnormalities

  33. The Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: From Day 1(first dose) to Day7

    The Number of participants with QTcF abnormalities

Sponsors and collaborators

Lead sponsor

Shanghai Vinnerna Biosciences Co., Ltd.

Industry

Collaborators

  • Sponsor GmbH

Registry information

Official study title

An Open-label, Single-dose, Phase I Study to Assess the Pharmacokinetics and Safety of JT001 in Subjects With Mild and Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.