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

NCT06671444 | Active Not Recruiting Phase 1

• 1 other identifier: YZJ-1139-1-12
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

Objective：

1. 1.To evaluate the pharmacokinetics of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment.
2. 2.To evaluate the safety of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment.

Conditions

Insomnia; Renal Impairment

Outcome Measures

Primary Outcomes (11)

• 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

  From Day 1 to Day 3

• 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

  From Day 1 to Day 3

• Maximum Observed Plasma Concentration (Cmax) of YZJ-1139

  Cmax is defined as the maximum concentration of drug

  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

  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

  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

  From Day 1 to Day 3

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

  From Day 1 to Day 3

• Mean Residence Time (MRT0-t) of YZJ-1139

  From Day 1 to Day 3

• Renal Excretion (Ae) of YZJ-1139

  From Day 1 to Day 3

• renal clearance (CLR) of YZJ-1139

  From Day 1 to Day 3

• Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Day 1 to Day 7

Study Arms (2)

Group A: Severe Renal Impairment

EXPERIMENTAL

Drug: YZJ-1139

Group B: Normal Renal Impairment

EXPERIMENTAL

Drug: YZJ-1139

Interventions

YZJ-1139 DRUG

Single oral dose, 20 mg tablet

Group A: Severe Renal Impairment; Group B: Normal Renal Impairment

Eligibility Criteria

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

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Shanghai Haiyan Pharmaceutical Technology Co., Ltd.: lead

Study Sites (3)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

Location

The First Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Renal Insufficiency

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

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

Model Details: single dose

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: June 3, 2024
• Primary Completion: November 10, 2024
• Study Completion: December 25, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Locations

CN (3)