InsomniaPhase 1NCT06671509
Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment
A Phase 1 study testing YZJ-1139 in people with Insomnia and Hepatic Impairment, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
Primary Objectives: To evaluate the effect of the subjects with mild (Child Pugh A), moderate (Child Pugh B) and normal hepatic impairment on the pharmacokinetics of YZJ-1139 Secondary Objectives: To evaluate the safety of a single oral dose of YZJ-1139 in subjects with mild, moderate and normal hepatic impairment Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Hepatic Impairment
- What is being tested?
- YZJ-1139
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2024to 7 Aug 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily sign an informed consent form before the start of activities related to this trial, and be able to understand the procedures and methods of this trial, willing to strictly follow the clinical trial protocol to complete this trial;
- The subjects (including partners) are willing to self screen and have no family planning within 3 months after the administration of the investigational drug, and voluntarily take contraceptive measures (see Appendix 1 for specific contraceptive measures);
- On the day of signing the informed consent form, the age range is 18 to 70 years old (including both ends), both men and women are eligible;
- The weight of male subjects shall not be less than 50 kg, and the weight of female subjects shall not be less than 45 kg; Body mass index (BMI) 18-32 kg/m2 (including both ends);
- Creatinine clearance rate (calculated using Cockcroft Gault formula, see Appendix 2) ≥ 60 mL/min;
- Subjects with liver dysfunction also need to meet all the following conditions:
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- Chronic liver injury caused by primary liver diseases (such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.) or clinically diagnosed as cirrhosis (see Appendix 3 for diagnostic criteria for cirrhosis), and liver dysfunction patients with Child Pugh grading of A or B (see Appendix 4 for Child Pugh grading).
- Individuals who have a stable medication regimen for the treatment of liver dysfunction, complications, and other accompanying diseases for at least 14 days prior to taking the investigational drug, and whose medication does not need to be adjusted (including medication type, dosage, or frequency); Or those who have not taken medication;
- Subjects with normal liver function also need to meet all the following conditions:
- The demographic mean of subjects in the normal liver function group (Group C) during screening must meet the following matching criteria:
- Match the weight with the liver function impairment group (Group A+Group B), with a mean of ± 10 kg;
- Age matched with the liver function impairment group (Group A+Group B), with a mean of ± 10 years;
- Match with the liver function impairment group (Group A+Group B) by gender, with a mean of ± 1 case;
Who cannot join
- Allergic constitution, such as those with a known history of allergies to two or more substances, or those with allergic diseases, or those with a history of allergies to experimental drugs or similar drugs or excipients;
- Screening period electrocardiogram showed QTc interval (QTcF)>470 msec in males and>480 msec in females (corrected according to Fridericia's standard: QTcF=QT/(RR ^ 0.33), RR=60/heart rate);
- Screening for individuals who have had severe infections, trauma, gastrointestinal surgery, or other surgical procedures within the first 4 weeks;
- Individuals with a history of paroxysmal sleep disorder, obstructive sleep apnea, complex sleep behavior (such as dream walking, driving in dreams, etc.), severe unconscious hypoglycemia, stroke, epilepsy, and other psychiatric disorders (including anxiety, depression, etc.), convulsive diseases, and sudden onset of illness;
- Individuals who have donated blood or lost ≥ 200 mL of blood within the first 3 months of screening, received blood transfusions or used blood products, or planned to donate blood during the trial period or within 1 month after the end of the trial;
- Individuals who have used CYP3A4 enzyme inducers or inhibitors within one month prior to administration (or five half-lives, whichever is longer) (see Appendix 5);
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- Individuals who have consumed 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, 200mL per cup) within 2 weeks prior to 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% spirits, or 150 mL of wine) or those who have tested positive for alcohol screening; Screening for individuals who smoke an average of 10 or more cigarettes per day within the first 3 months;
- Individuals with a history of drug use, drug abuse, or positive drug abuse screening;
- Pregnant or lactating women, or women who test positive for pregnancy;
- Patients with difficulty swallowing tablets and special dietary requirements who cannot accept a unified diet;
- Individuals who cannot tolerate venous puncture or have a history of needle and blood fainting;
- For other reasons, researchers believe that it is not suitable for inclusion;
- If a subject with liver function impairment meets any of the following exclusion criteria, they need to be excluded:
- The subject has any of the following conditions: drug-induced liver injury; History of liver transplantation; Cirrhotic patients with liver failure, hepatic encephalopathy, hepatocellular carcinoma (excluding those with Barcelona stage 0 or curative treatment), hepatorenal syndrome, esophageal and gastric variceal bleeding and other complications deemed inappropriate by researchers;
- Patients with primary biliary cirrhosis and biliary obstruction;
- The laboratory test results during screening meet any of the following criteria: (a) alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>10 × ULN; (b) Absolute value of neutrophils (NE #)<0.75 × 109/L; (c) Hemoglobin (HGB)<60 g/L; (d) Alpha fetoprotein (AFP)>100 ng/mL;
- HIV antigen/antibody screening positive individuals; If syphilis antibody is positive, a rapid plasma reactive receptor (RPR) test should be added. If RPR is also positive, it should be excluded;
- Except for the primary liver disease itself, those who have previously or currently suffered from other serious systemic organ diseases, including but not limited to gastrointestinal, respiratory, renal, neurological, blood, endocrine, tumor, immune, psychiatric or cardiovascular diseases, or clinical laboratory examination abnormalities that are clinically significant and determined by the research doctor to be unsuitable for participation in this trial;
- Screening for individuals who have used other clinical trial drugs within the first two months or plan to participate in other clinical trials during this study period;
- Subjects with normal liver function who meet any of the following exclusion criteria need to be excluded:
- Individuals with a history of liver injury;
- Individuals who have previously or currently suffered from any clinically severe diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases that can interfere with test results;
- Abnormal physical examination, vital signs, laboratory tests, 12 lead electrocardiogram, abdominal ultrasound, and other examinations 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;
- Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or supplements within 14 days before administration;
- Screening for individuals who have used other clinical trial drugs or plan to participate in other clinical trials during the first three months of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-Label Single-Dose Study to Assess the Pharmacokinetics and Safety of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment
Primary Objectives:
To evaluate the effect of the subjects with mild (Child Pugh A), moderate (Child Pugh B) and normal hepatic impairment on the pharmacokinetics of YZJ-1139
Secondary Objectives:
To evaluate the safety of a single oral dose of YZJ-1139 in subjects with mild, moderate and normal hepatic impairment
- Conditions
- Insomnia, Hepatic Impairment
- Being tested
- YZJ-1139
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YZJ-1139Drug
Single oral dose, 20 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Group A: Mild Hepatic Impairment | Experimental | Not described Receives: Drug: YZJ-1139 |
| Group B: Moderate Hepatic Impairment | Experimental | Not described Receives: Drug: YZJ-1139 |
| Group C: Normal Hepatic Impairment | Experimental | Not described Receives: Drug: YZJ-1139 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of YZJ-1139
Cmax is defined as the maximum concentration of drug
Measured: From Day 1 to Day 3
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of YZJ-1139
AUCinf is defined as the concentration of drug extrapolated to infinite time
Measured: From Day 1 to Day 3
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUClast) of YZJ-1139
AUClast is defined as the concentration of drug from time zero to the last observable concentration
Measured: From Day 1 to Day 3
Time of Maximum Observed Plasma Concentration (Tmax) of Entrectinib
Tmax is defined as the time (observed time point) of Cmax.
Measured: From Day 1 to Day 3
Apparent Terminal Elimination Half-life (t1/2) of Entrectinib
Measured: From Day 1 to Day 3
Apparent Oral Clearance (CL/F) of Entrectinib
CL/F is defined as the apparent oral clearance following administration of the drug
Measured: From Day 1 to Day 3
The Apparent Volume of Distribution (Vz/F) of Entrectinib
Vz/F is defined as the apparent volume of distribution of the drug
Measured: From Day 1 to Day 3
Secondary outcomes (1)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Day 1 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 posted4 Nov 2024
- Study start22 Mar 2024
- Primary completion18 Apr 2024
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Model description
- Single dose
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671509
- Sponsor's protocol ID
- YZJ-1139-1-11
- Status last verified
- Oct 2024
- First submitted
- 1 Nov 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Single-Dose Study to Assess the Pharmacokinetics and Safety of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment
- ClinicalTrials.gov ID
- NCT06671509
- Acronym / sponsor ID
- YZJ-1139-1-11
- Conditions
- Insomnia, Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 4 Nov 2024 (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.
Primary Objectives:
To evaluate the effect of the subjects with mild (Child Pugh A), moderate (Child Pugh B) and normal hepatic impairment on the pharmacokinetics of YZJ-1139
Secondary Objectives:
To evaluate the safety of a single oral dose of YZJ-1139 in subjects with mild, moderate and normal hepatic impairment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single dose
| Arm | Type | Receives |
|---|---|---|
| Group A: Mild Hepatic Impairment | Experimental | Drug: YZJ-1139 |
| Group B: Moderate Hepatic Impairment | Experimental | Drug: YZJ-1139 |
| Group C: Normal Hepatic Impairment | Experimental | Drug: YZJ-1139 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntarily sign an informed consent form before the start of activities related to this trial, and be able to understand the procedures and methods of this trial, willing to strictly follow the clinical trial protocol to complete this trial;
- The subjects (including partners) are willing to self screen and have no family planning within 3 months after the administration of the investigational drug, and voluntarily take contraceptive measures (see Appendix 1 for specific contraceptive measures);
- On the day of signing the informed consent form, the age range is 18 to 70 years old (including both ends), both men and women are eligible;
- The weight of male subjects shall not be less than 50 kg, and the weight of female subjects shall not be less than 45 kg; Body mass index (BMI) 18-32 kg/m2 (including both ends);
- Creatinine clearance rate (calculated using Cockcroft Gault formula, see Appendix 2) ≥ 60 mL/min;
Key exclusion criteria (27 listed)
- Allergic constitution, such as those with a known history of allergies to two or more substances, or those with allergic diseases, or those with a history of allergies to experimental drugs or similar drugs or excipients;
- Screening period electrocardiogram showed QTc interval (QTcF)>470 msec in males and>480 msec in females (corrected according to Fridericia's standard: QTcF=QT/(RR ^ 0.33), RR=60/heart rate);
- Screening for individuals who have had severe infections, trauma, gastrointestinal surgery, or other surgical procedures within the first 4 weeks;
- Individuals with a history of paroxysmal sleep disorder, obstructive sleep apnea, complex sleep behavior (such as dream walking, driving in dreams, etc.), severe unconscious hypoglycemia, stroke, epilepsy, and other psychiatric disorders (including anxiety, depression, etc.), convulsive diseases, and sudden onset of illness;
- Individuals who have donated blood or lost ≥ 200 mL of blood within the first 3 months of screening, received blood transfusions or used blood products, or planned to donate blood during the trial period or within 1 month after the end of the trial;
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 |
|---|---|---|
| YZJ-1139Single oral dose, 20 mg tablet | Drug | Group A: Mild Hepatic Impairment, Group B: Moderate Hepatic Impairment, Group C: Normal Hepatic Impairment |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of YZJ-1139
Time frame: From Day 1 to Day 3
Cmax is defined as the maximum concentration of drug
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of YZJ-1139
Time frame: From Day 1 to Day 3
AUCinf is defined as the concentration of drug extrapolated to infinite time
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUClast) of YZJ-1139
Time frame: From Day 1 to Day 3
AUClast is defined as the concentration of drug from time zero to the last observable concentration
Time of Maximum Observed Plasma Concentration (Tmax) of Entrectinib
Time frame: From Day 1 to Day 3
Tmax is defined as the time (observed time point) of Cmax.
Apparent Terminal Elimination Half-life (t1/2) of Entrectinib
Time frame: From Day 1 to Day 3
Apparent Oral Clearance (CL/F) of Entrectinib
Time frame: From Day 1 to Day 3
CL/F is defined as the apparent oral clearance following administration of the drug
The Apparent Volume of Distribution (Vz/F) of Entrectinib
Time frame: From Day 1 to Day 3
Vz/F is defined as the apparent volume of distribution of the drug
1 secondary outcome
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 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 4 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YZJ-1139 in people with Insomnia and Hepatic Impairment, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 1 site in China.
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 13 inclusion and 27 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 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Maximum Observed Plasma Concentration (Cmax) of YZJ-1139 (time frame: From Day 1 to Day 3). The study lists 7 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 4 Nov 2024.