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

NCT06093230 | Completed Phase 1

• 1 other identifier: JT001-007-I
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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;

Conditions

Subjects With Liver Function Injury; Normal Liver Function Subject

Outcome Measures

Primary Outcomes (33)

• The Cmax of the main metabolite 116-N1 of JT001;

  maximum observed plasma concentration

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

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

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

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

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

  area under curve from time zero to infinity

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

• Tmax of the main metabolite 116-N1 of JT001;

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

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

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

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

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

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

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

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

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

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

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

• The severity of SAE

  The severity of SAE

  From Day 1(first dose) to Day7

• The Number of participants with SAE

  The Number of participants with SAE

  From Day 1(first dose) to Day7

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

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

  From Day 1(first dose) to Day7

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

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

  From Day 1(first dose) to Day7

• The severity of vital signs abnormalities

  The severity of Pulse abnormalities

  From Day 1(first dose) to Day7

• The Number of participantswith abnormal vital signs

  The Number of participantswith abnormal Pulse

  From Day 1(first dose) to Day7

• The severity of vital signs abnormalities

  The severity of blood pressure abnormalities

  From Day 1(first dose) to Day7

• The Number of participantswith abnormal vital signs

  The Number of participantswith abnormal blood pressure

  From Day 1(first dose) to Day7

• The severity of vital signs abnormalities

  The severity of respiration abnormalities

  From Day 1(first dose) to Day7

• The Number of participantswith abnormal vital signs

  The Number of participantswith abnormal respiration

  From Day 1(first dose) to Day7

• The severity of vital signs abnormalities

  The severity of body temperature abnormalities

  From Day 1(first dose) to Day7

• The Number of participantswith abnormal vital signs

  The Number of participantswith abnormal body temperature

  From Day 1(first dose) to Day7

• The severity of abnormal physical examinations findings

  The severity of abnormal physical examinations findings

  From Day 1(first dose) to Day7

• The Number of participantswith abnormal physical examinations findings

  The Number of participantswith abnormal physical examinations findings

  From Day 1(first dose) to Day7

• The severity of abnormal laboratory tests results

  The severity of abnormal laboratory tests results

  From Day 1(first dose) to Day7

• The Number of participantswith abnormal laboratory tests results

  The Number of participantswith abnormal laboratory tests results

  From Day 1(first dose) to Day7

• The severity of electrocardiogram (ECG) abnormalities

  The severity of Heart rate abnormalities

  From Day 1(first dose) to Day7

• The Number of participants with electrocardiogram (ECG) abnormalities

  The Number of participants with Heart rate abnormalities

  From Day 1(first dose) to Day7

• The severity of electrocardiogram (ECG) abnormalities

  The severity of PR interval abnormalities

  From Day 1(first dose) to Day7

• The Number of participants with electrocardiogram (ECG) abnormalities

  The Number of participants with PR interval abnormalities

  From Day 1(first dose) to Day7

• The severity of electrocardiogram (ECG) abnormalities

  The severity of QRS interval abnormalities

  From Day 1(first dose) to Day7

• The Number of participants with electrocardiogram (ECG) abnormalities

  The Number of participants with QRS interval abnormalities

  From Day 1(first dose) to Day7

• The severity of electrocardiogram (ECG) abnormalities

  The severity of QT interval abnormalities

  From Day 1(first dose) to Day7

• The Number of participants with electrocardiogram (ECG) abnormalities

  The Number of participants with QT interval abnormalities

  From Day 1(first dose) to Day7

• The severity of electrocardiogram (ECG) abnormalities

  The severity of QTcF abnormalities

  From Day 1(first dose) to Day7

• The Number of participants with electrocardiogram (ECG) abnormalities

  The Number of participants with QTcF abnormalities

  From Day 1(first dose) to Day7

Study Arms (3)

Group A

EXPERIMENTAL

mild liver function impairment group

Drug: Deuremidevir Hydrobromide Tablets

Group B

EXPERIMENTAL

moderate liver function impairment group

Drug: Deuremidevir Hydrobromide Tablets

Group C

EXPERIMENTAL

normal liver function subject group

Drug: Deuremidevir Hydrobromide Tablets

Interventions

Deuremidevir Hydrobromide Tablets DRUG

JT001 single dose, 0.3g

Also known as: JT001

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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;
• 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;

Sponsors & Collaborators

• Shanghai Vinnerna Biosciences Co., Ltd.: lead
• Sponsor GmbH: collaborator

Study Sites (1)

The First Hospital of Jilin University Ethics Committee

Changchun, Jilin, 130021, China

Location

MeSH Terms

Interventions

GS-621763

Study Officials

• Huiyu Lan, Project Director

  Shanghai Vinnerna Biosciences Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 23, 2023
• Study Start: July 28, 2023
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-09

Locations

CN (1)