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InsomniaPhase 1NCT06671444

Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Severe Renal Impairment and Normal Renal Impairment

A Phase 1 study testing YZJ-1139 in people with Insomnia and Renal Impairment, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective： 1. To evaluate the pharmacokinetics of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment. 2. To evaluate the safety of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Insomnia, Renal 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
16 participants
Where
3 sitesChina
Study dates
3 Jun 2024to 6 Nov 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Allergic constitution, such as those with a known history of allergies to drugs, food or other substances, or those with a history of allergies to YZJ-1139 tablets or similar orexin receptor antagonist drugs and excipients;
  • Subjects with difficulty swallowing tablets, and special dietary requirements who cannot accept a unified diet;
  • Subjects who have poor peripheral venous access or cannot tolerate venous puncture or have a history of needle and blood fainting;
  • Subjects who have undergone surgery within 30 days prior to screening, or plan to undergo surgery during the study;
  • 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;
  • Patients who have received kidney transplantation and/or require renal dialysis during the trial.
Show all 52Show fewer
  • Except for the disease causing renal dysfunction itself, those who have previously or currently suffered from other serious systemic organ diseases, including respiratory, digestive, endocrine, malignant tumor, blood, mental/nervous system serious diseases, which were judged by the investigator to be unsuitable for participation in this trial;
  • Subjects with ALT and/or AST > 2 ULN and/or TBIL > 1.5 ULN, Hb < 80 g/L, QTcF > 450 ms in males and QTcF > 470 ms in females by ECG.
  • Subjects with poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or heart rate > 120bmp.
  • Patients with diabetic nephropathy HbAlc (glycosylated hemoglobin) > 8.5% or fasting blood glucose > 8.5 mmol/L, or stable treatment regimen for less than 1 month before screening.
  • Subjects with active HBV infection (HBV DNA copy number ≥ 104 copies/mL must be excluded if HBsAg is positive), or those who are positive in any index screening of HCV, human immunodeficiency virus antibody, syphilis antibody.
  • Subjects with a history of drug abuse, drug use within 6 months before screening, or positive drug abuse screening;
  • Subjects who frequently consume alcohol within 3 months prior to screening, i.e., consuming 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 who cannot stop using any alcohol products during the study, or alcohol breath test result > 0.0 mg/100 mL;
  • Subjects who have donated blood or experienced massive blood loss (> 400 mL) within 3 months prior to screening, received blood transfusions or used blood products, planned to donate blood during the trial period or within 1 month after the end of the trial;
  • Subjects who have consumed excessive tea, coffee and/or caffeine-containing beverages (more than 8 cups, 1 cup ≈ 250 mL) daily during the 3 months before screening;
  • Subjects smoke an average of 5 or more cigarettes per day within 3 months prior to screening, or those who cannot stop using any tobacco products during the study;
  • Subjects who have participated in any clinical trial and have used clinical trial drugs within 3 months prior to screening, or plan to participate in other clinical trials during the study;
  • Subjects who have received vaccination within 30 days prior to screening, or plan to receive vaccination during the study;
  • Subjects who have used any CYP3A4 enzyme inducer or inhibitor within 30 days (or 5 half-lives, whichever is longer) prior to administration;
  • Subjects who have used any prescription drugs, over-the-counter drugs, vitamin products, health products or Chinese herbal medicines other than those for the treatment of renal insufficiency and or its concomitant chronic diseases within 14 days before administration;
  • Subjects who started taking new drugs, dosage forms or adjusted current doses for the treatment of chronic kidney disease and its combined chronic diseases within 14 days before administration;
  • Subjects who have consumed special diets (including grapefruit, chocolate, xanthine-rich or alcohol-rich foods/beverages) within 48 h before administration;
  • Lactating women, or women who test positive for pregnancy;
  • Subjects with acute illness from screening to prior to administration;
  • Those who, in the opinion of the investigator, are not suitable for inclusion.
  • Entry criteria（Group B-Healthy Subject Group）:
  • Subjects aged 18 to 65 years (inclusive), matched with renal impairment for age and sex (each subject in Group B within± 10 years of the mean for Group A and with a mean of ± 1 case for Group A by gender)；
  • Weight ≥ 50.0 kg for males, or ≥ 45.0 kg for females, and body mass index (BMI) in the range of 19.0 ~ 28.0 kg/m2 (inclusive), matched to BMI with renal impairment group (each subject in Group B within ±15% of mean in Group A by BMI).
  • Normal renal function, 90 mL/min ≤ absolute eGFR < 130 mL/min;
  • Subjects with normal physical examination, vital signs (normal range refers to central SOP), 12-lead ECG, laboratory tests, imaging and abdominal ultrasonography results during the screening period or abnormal but no clinical significance as judged by the investigator;
  • Subjects of childbearing potential (including partners) have no family planning or donate sperm/eggs from 2 weeks before screening to 3 months after dosing, and voluntarily take appropriate contraceptive measures;
  • Subjects who are able to understand and willing to complete the study in strict compliance with the clinical protocol and sign the informed consent form.
  • Allergic constitution, such as those with a known history of allergies to drugs, food or other substances, or those with a history of allergies to YZJ-1139 tablets or similar orexin receptor antagonist drugs and excipients;
  • Subjects with difficulty swallowing tablets, and special dietary requirements who cannot accept a unified diet;
  • Subjects who have poor peripheral venous access or cannot tolerate venous puncture or have a history of needle and blood fainting;
  • 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;
  • Subjects who have a history of other serious diseases and chronic diseases such as respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system;
  • Those who are positive in any index screening of hepatitis B virus surface antigen, Treponema pallidum-specific antibody, human immunodeficiency virus antibody,or hepatitis C virus antibody；
  • 12) Subjects with a history of drug abuse, drug use within 6 months before screening, or positive drug abuse screening;
  • Subjects who frequently consume alcohol within 3 months prior to screening, i.e., consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% spirits, alcohol or 150 mL of wine), or who cannot stop using any alcohol products during the study, or whose alcohol breath test result > 0.0 mg/100 mL;
  • Subjects who have donated blood or experienced massive blood loss (> 400 mL) within 3 months prior to screening, received blood transfusions or used blood products, planned to donate blood during the trial period or within 1 month after the end of the trial;
  • Subjects who have consumed excessive tea, coffee and/or caffeine-containing beverages (more than 8 cups, 1 cup ≈ 250 mL) daily during the 3 months before screening;
  • Subjects smoke an average of 5 or more cigarettes per day within 3 months prior to screening, or those who cannot stop using any tobacco products during the study;
  • Subjects who have participated in any clinical trial and have used clinical trial drugs within 3 months prior to screening, or plan to participate in other clinical trials during the study;
  • Subjects who have undergone surgery within 30 days prior to screening, or plan to undergo surgery during the study;
  • Subjects who have received vaccination within 30 days prior to screening, or plan to receive vaccination during the study;
  • Subjects who have used any CYP3A4 enzyme inducer or inhibitor within 30 days (or 5 half-lives, whichever is longer) prior to administration;
  • Subjects who have taken any prescription drugs, over-the-counter drugs, health products, vitamins, and Chinese herbal medicines within 14 days before administration;
  • Subjects who have consumed special diets (including grapefruit, chocolate, xanthine-rich or alcohol-rich foods/beverages) within 48 h before administration;
  • Lactating women, or women who test positive for pregnancy;
  • Subjects with acute illness from screening period to pre-dose;
  • Those who, in the opinion of the investigator, are not suitable for inclusion.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu

  • The First Affiliated Hospital of Xuzhou Medical University

    Xuzhou

Other trials in China

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 Severe Renal Impairment and Renal Impairment

Objective：

  1. To evaluate the pharmacokinetics of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment.
  2. To evaluate the safety of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment.
Being tested
YZJ-1139
Medical subject headings
Sleep Initiation and Maintenance Disorders, Renal Insufficiency

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 groups in NCT06671444
Study groupRoleWhat they receive
Group A: Severe Renal ImpairmentExperimentalNot described
Receives: Drug: YZJ-1139
Group B: Normal Renal ImpairmentExperimentalNot described
Receives: Drug: YZJ-1139

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) 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

  2. Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of YZJ-1139

    AUCinf is defined as the concentration of drug extrapolated to infinite time

    Measured: From Day 1 to Day 3

  3. Maximum Observed Plasma Concentration (Cmax) of YZJ-1139

    Cmax is defined as the maximum concentration of drug

    Measured: From Day 1 to Day 3

  4. 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

  5. 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

  6. 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

  7. Apparent Terminal Elimination Half-life (t1/2) of Entrectinib

    Measured: From Day 1 to Day 3

  8. Mean Residence Time (MRT0-t) of YZJ-1139

    Measured: From Day 1 to Day 3

  9. Renal Excretion (Ae) of YZJ-1139

    Measured: From Day 1 to Day 3

  10. renal clearance (CLR) of YZJ-1139

    Measured: From Day 1 to Day 3

  11. 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.

  1. First posted4 Nov 2024
  2. Study start3 Jun 2024
  3. Primary completion11 Oct 2024
  4. Study completion6 Nov 2024

Resources

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
Single group
Model description
single dose
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06671444
Sponsor's protocol ID
YZJ-1139-1-12
Status last verified
Jun 2026
First submitted
31 Oct 2024
Last updated
30 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YZJ-1139 in people with Insomnia and Renal Impairment, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 3 sites 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 0 inclusion and 52 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of YZJ-1139 (time frame: From Day 1 to Day 3). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06671444.

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 30 Jun 2026.

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