PK/PD Study of YZJ-1139 | NCT06685341

NCT06685341

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Drug: YZJ-1139 high dose group	Experimental	Subjects will be into two groups：Young adult subjects and elderly subjects	Drug: YZJ-1139
Drug: YZJ-1139 low dose group	Experimental	Subjects will be into two groups：Young adult subjects and elderly subjects	Drug: YZJ-1139
Drug: Placebo	Placebo Comparator		Drug: Placebo
Drug: Zolpidem	Active Comparator		Drug: Zolpidem

Name	Type	Description	Arm Group Labels	Other Names
YZJ-1139	Drug	YZJ-1139	Drug: YZJ-1139 high dose group Drug: YZJ-1139 low dose group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax of YZJ-1139、zolpidem	Cmax is defined as the maximum concentration of drug	From Day 1 to Day 2 post single dose；up to 4 weeks
AUCinf of YZJ-1139、zolpidem	AUCinf is defined as the concentration of drug extrapolated to infinite time	From Day 1 to Day 2 post single dose；up to 4 weeks
AUClast of YZJ-1139、zolpidem	AUClast is defined as the concentration of drug from time zero to the last observable concentration	From Day 1 to Day 2 post single dose；up to 4 weeks
Tmax of YZJ-1139、zolpidem	Tmax is defined as the time (observed time point) of Cmax	From Day 1 to Day 2 post single dose；up to 4 weeks
t1/2 of YZJ-1139、zolpidem		From Day 1 to Day 2 post single dose；up to 4 weeks
CL/F of YZJ-1139、zolpidem	CL/F is defined as the apparent oral clearance following administration of the drug	From Day 1 to Day 2 post single dose；up to 4 weeks
Vz/F of YZJ-1139、zolpidem	Vz/F is defined as the apparent volume of distribution of the drug	From Day 1 to Day 2 post single dose；up to 4 weeks
Left and right saccade peak velocity (SPV) of Eye Movements

Measure	Description	Time Frame
Adverse events (AEs)		From Day 1 to Day 2 post single dose；up to 4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

History of heart, liver, lung, kidney, digestive tract, blood system, neuropsychiatric system and other diseases, including anxiety and depression, that researchers deem clinically significant;
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;
Poor compliance with the pharmacodynamics training before administration;
Have taken any medication in the two weeks prior to study administration, and the investigator judges it may affect the evaluation results;
History of food and drug allergy or allergic reaction that the researcher determines to be clinically significant;
Serological examination (HBsAg, anti-HCV, anti-HIV, TP-Ab) with positive results;
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;
Frequent (> 1 time per month) use of hypnotic drugs, and screening and baseline benzodiazepine urine screening positive;
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;
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;
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);
Participants who have participated in any drug clinical trial as a subject within 3 months prior to study administration;
Patients who donated blood or blood products ≥400 mL or 2 units within three months prior to drug administration;
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;
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;
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;
Those with abnormal cognitive function assessment (MMSE less than 26 points) and judged by the researchers to be clinically significant;
Subjects deemed unsuitable for this clinical study by the investigator.

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds