Clinical trial NCT06685341: PK/PD Study of YZJ-1139
Official title: A Randomized, Double-Blind, Zolpidem and Placebo-Controlled, 4-Way-Period Crossover, Pharmacokinetics and Pharmacodynamics Study of YZJ-1139 Single-Dose Oral in Healthy Young and Elderly Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insomnia
Lead sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single dose, four-cycle crossover
Primary purpose: TREATMENT

Brief summary: Primary Objective： To determine the dose-response relationship of YZJ-1139 in young and elderly Chinese subjects after a single oral administration of different doses, and to compare it with zolpidem at clinical doses.

Secondary Objective: To investigate the safety and tolerability of YZJ-1139 in young and elderly Chinese subjects after a single oral administration of different doses, and to compare it with zolpidem at clinical doses.


Eligibility criteria: Inclusion Criteria:

1. Young adults and elderly Chinese healthy subjects, both male and female;
2. Age: \[young adult group\] 18-45 years old (including the threshold value); \[Elderly group\]65\~75 years old (including the cut-off value);
3. Body weight \[only for young adults\]: ≥50kg, BMI: 18\~28kg/m2 (including the threshold value);
4. Understand and sign the informed consent to participate in the study.

Exclusion Criteria:

1. History of heart, liver, lung, kidney, digestive tract, blood system, neuropsychiatric system and other diseases, including anxiety and depression, that researchers deem clinically significant;
2. Comprehensive physical examination, neurological examination, laboratory examination, ECG examination, etc. indicate that the subject has abnormalities that are judged by the researcher as clinically significant;
3. Poor compliance with the pharmacodynamics training before administration;
4. Have taken any medication in the two weeks prior to study administration, and the investigator judges it may affect the evaluation results;
5. History of food and drug allergy or allergic reaction that the researcher determines to be clinically significant;
6. Serological examination (HBsAg, anti-HCV, anti-HIV, TP-Ab) with positive results;
7. History of alcohol or drug abuse within the year prior to study administration that the investigators believe may have affected the results assessed in this study;
8. Frequent (\> 1 time per month) use of hypnotic drugs, and screening and baseline benzodiazepine urine screening positive;
9. Participants who need to work night shifts, stay up late, or stay at least 3 time zones away from the study site within 2 weeks before and during the study;
10. Subjects who could not maintain a regular sleep and rest schedule (get up at 6-8 am and go to sleep at 10-12 PM) within 1 week before and during the study and who were judged by the investigator to be likely to affect the results of this study;
11. Those who could not quit smoking and alcohol drinking as required during the study period or whose carbon monoxide breath test detected \>7 ppm during the screening period (further confirmation by urine cotinine test if deemed necessary by the investigators);
12. Participants who have participated in any drug clinical trial as a subject within 3 months prior to study administration;
13. Patients who donated blood or blood products ≥400 mL or 2 units within three months prior to drug administration;
14. Those who do not agree to avoid the use of tobacco, alcohol or caffeinated beverages, or to avoid strenuous exercise, or to avoid other factors affecting the absorption, distribution, metabolism or excretion of drugs within 24 hours before and during the trial;
15. Don't agree or is unable to refrain from eating grapefruit or other related tropical fruits and beverages and from using St. John's Wort during the 24 hours prior to the first dose and during the study period;
16. Women who are pregnant or nursing, or who test positive for serum HCG before trial administration, or who cannot/do not use investigator-approved contraception during the study as required;
17. Those with abnormal cognitive function assessment (MMSE less than 26 points) and judged by the researchers to be clinically significant;
18. Subjects deemed unsuitable for this clinical study by the investigator.

Primary outcomes:
measure: Cmax of YZJ-1139、zolpidem
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: AUCinf of YZJ-1139、zolpidem
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: AUClast of YZJ-1139、zolpidem
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: Tmax of YZJ-1139、zolpidem
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: t1/2 of YZJ-1139、zolpidem
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: CL/F of YZJ-1139、zolpidem
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: Vz/F of YZJ-1139、zolpidem
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: Left and right saccade peak velocity (SPV) of Eye Movements
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: left and right saccade accuracy rate (SacAcc) of Eye Movements
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: Left and right saccade eye movement response time (SacRT) of Eye Movements
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: Smooth eye movement to the left and right (Smooth) of Eye Movements
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: Body Sway
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: Simple response time of Choice Reaction Time Test
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: Simple response accuracy rate of Choice Reaction Time Test
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: Selective response time of Choice Reaction Time Test
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: Selective response accuracy rate of Choice Reaction Time Test
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: The average reaction time for correct responses of Digit Symbol Substitution Test
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: The number of correct responses of Digit Symbol Substitution Test
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: The average reaction time for incorrect responses of Digit Symbol Substitution Test
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: The number of incorrect responses of Digit Symbol Substitution Test
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: The number of non-responses of Digit Symbol Substitution Test
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: Immediate recall of Word Recall Test
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: Delayed recall of Word Recall Test
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
measure: Delayed recognition of Word Recall Test
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: From Day 1 to Day 2 post single dose；up to 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
References: