InsomniaPhase 1NCT06685341
PK/PD Study of YZJ-1139
A Phase 1 study testing YZJ-1139 and Zolpidem in people with Insomnia, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insomnia
- What is being tested?
- YZJ-1139 and Zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2019to 15 Nov 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Insomnia
- Being tested
- YZJ-1139, Placebo, Zolpidem
- 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
YZJ-1139
PlaceboDrug
Oral tablet
ZolpidemDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Drug: YZJ-1139 high dose group | Experimental | Subjects will be into two groups：Young adult subjects and elderly subjects Receives: Drug: YZJ-1139 |
| Drug: YZJ-1139 low dose group | Experimental | Subjects will be into two groups：Young adult subjects and elderly subjects Receives: Drug: YZJ-1139 |
| Drug: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Drug: Zolpidem | Active comparator | Not described Receives: Drug: Zolpidem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of YZJ-1139、zolpidem
Cmax is defined as the maximum concentration of drug
Measured: 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
Measured: 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
Measured: 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
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
t1/2 of YZJ-1139、zolpidem
Measured: 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
Measured: 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
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
Left and right saccade peak velocity (SPV) of Eye Movements
Instruct the subject to fix their gaze on the red light spot on the LED display and move their eyes with the light spot. During the test, the head and body must remain still. The test consists of the following two parts, each lasting 2 minutes. Between the two parts, the subject should rest for a certain period of time based on their level of fatigue.
Part 1: Scanning eye movements Part 2: Smooth pursuit eye movements.
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
left and right saccade accuracy rate (SacAcc) of Eye Movements
Instruct the subject to fix their gaze on the red light spot on the LED display and move their eyes with the light spot. During the test, the head and body must remain still. The test consists of the following two parts, each lasting 2 minutes. Between the two parts, the subject should rest for a certain period of time based on their level of fatigue.
Part 1: Scanning eye movements Part 2: Smooth pursuit eye movements.
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
Left and right saccade eye movement response time (SacRT) of Eye Movements
Instruct the subject to fix their gaze on the red light spot on the LED display and move their eyes with the light spot. During the test, the head and body must remain still. The test consists of the following two parts, each lasting 2 minutes. Between the two parts, the subject should rest for a certain period of time based on their level of fatigue.
Part 1: Scanning eye movements Part 2: Smooth pursuit eye movements.
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
Smooth eye movement to the left and right (Smooth) of Eye Movements
Instruct the subject to fix their gaze on the red light spot on the LED display and move their eyes with the light spot. During the test, the head and body must remain still. The test consists of the following two parts, each lasting 2 minutes. Between the two parts, the subject should rest for a certain period of time based on their level of fatigue.
Part 1: Scanning eye movements Part 2: Smooth pursuit eye movements.
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
Body Sway
The subject takes off their shoes, spreads their feet shoulder-width apart, and stands on a flat ground 120 cm away from the measuring device. They close their eyes and stand for 2 minutes, and the test measures the body sway amplitude (mm) of the subject during the 2-minute closed-eye period. The test evaluates the subject's postural balance
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
Simple response time of Choice Reaction Time Test
The test lasts for 1 minute. During the test, there is a vertical line in the center of the screen. On both sides of the screen, random "left" or "right" words will appear. The participants are required to ignore the word meanings and click the "right" or "left" key based on the word's position.
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
Simple response accuracy rate of Choice Reaction Time Test
The test lasts for 1 minute. During the test, there is a vertical line in the center of the screen. On both sides of the screen, random "left" or "right" words will appear. The participants are required to ignore the word meanings and click the "right" or "left" key based on the word's position.
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
Selective response time of Choice Reaction Time Test
During the test, there was a dividing line in the middle of the screen. During the test, the word "left" or "right" appeared randomly on both sides of the screen. Subjects were asked to ignore the position of the word and click the key "right" or "left" according to the meaning of the word.
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
Selective response accuracy rate of Choice Reaction Time Test
During the test, there was a dividing line in the middle of the screen. During the test, the word "left" or "right" appeared randomly on both sides of the screen. Subjects were asked to ignore the position of the word and click the key "right" or "left" according to the meaning of the word.
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
The average reaction time for correct responses of Digit Symbol Substitution Test
The test time is not more than 2 minutes, the symbol is displayed on the screen, and the subject clicks the corresponding number according to the corresponding relationship between the symbol and the number given below. After clicking or exceeding the upper limit of the reaction time, the subject automatically enters the next symbol.
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
The number of correct responses of Digit Symbol Substitution Test
The test time is not more than 2 minutes, the symbol is displayed on the screen, and the subject clicks the corresponding number according to the corresponding relationship between the symbol and the number given below. After clicking or exceeding the upper limit of the reaction time, the subject automatically enters the next symbol.
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
The average reaction time for incorrect responses of Digit Symbol Substitution Test
The test time is not more than 2 minutes, the symbol is displayed on the screen, and the subject clicks the corresponding number according to the corresponding relationship between the symbol and the number given below. After clicking or exceeding the upper limit of the reaction time, the subject automatically enters the next symbol.
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
The number of incorrect responses of Digit Symbol Substitution Test
The test time is not more than 2 minutes, the symbol is displayed on the screen, and the subject clicks the corresponding number according to the corresponding relationship between the symbol and the number given below. After clicking or exceeding the upper limit of the reaction time, the subject automatically enters the next symbol.
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
The number of non-responses of Digit Symbol Substitution Test
The test time is not more than 2 minutes, the symbol is displayed on the screen, and the subject clicks the corresponding number according to the corresponding relationship between the symbol and the number given below. After clicking or exceeding the upper limit of the reaction time, the subject automatically enters the next symbol.
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
Immediate recall of Word Recall Test
About 1-2 hours after dosing， First, the subjects were shown 20 unrelated words, each word for a few seconds, and then the subjects were asked to immediately recall the words they just saw.
The number of correct words in instantaneous recall was recorded respectively
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
Delayed recall of Word Recall Test
About 1-2 hours later, the subjects were allowed to freely recall the words again, which was delayed recall; The number of correct words in delayed recall was recorded respectively
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
Delayed recognition of Word Recall Test
The subjects were then presented with 40 words (of which 20 were previously presented words and 20 were confounding words), and were asked to answer one by one whether they were the words they had just seen.
The number of correct words in delayed extraction was recorded respectively
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
Secondary outcomes (1)
Adverse events (AEs)
Measured: From Day 1 to Day 2 post single dose；up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start7 Mar 2019
- Primary completion10 Apr 2019
- Study completion15 Nov 2019
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
- Randomised
- Intervention model
- Crossover
- Model description
- Single dose, four-cycle crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT06685341
- Sponsor's protocol ID
- YZJ-1139-1-02
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 12 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06685341
- Acronym / sponsor ID
- YZJ-1139-1-02
- Conditions
- Insomnia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 12 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Single dose, four-cycle crossover
| Arm | Type | Receives |
|---|---|---|
| Drug: YZJ-1139 high dose group | Experimental | Drug: YZJ-1139Subjects will be into two groups：Young adult subjects and elderly subjects |
| Drug: YZJ-1139 low dose group | Experimental | Drug: YZJ-1139Subjects will be into two groups：Young adult subjects and elderly subjects |
| Drug: Placebo | Placebo comparator | Drug: Placebo |
| Drug: Zolpidem | Active comparator | Drug: Zolpidem |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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;
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-1139YZJ-1139 | Drug | Drug: YZJ-1139 high dose group, Drug: YZJ-1139 low dose group |
| PlaceboOral tablet | Drug | Drug: Placebo |
| ZolpidemOral tablet | Drug | Drug: Zolpidem |
Primary outcome
Cmax of YZJ-1139、zolpidem
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
Cmax is defined as the maximum concentration of drug
AUCinf of YZJ-1139、zolpidem
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
AUCinf is defined as the concentration of drug extrapolated to infinite time
AUClast of YZJ-1139、zolpidem
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
AUClast is defined as the concentration of drug from time zero to the last observable concentration
Tmax of YZJ-1139、zolpidem
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
Tmax is defined as the time (observed time point) of Cmax
t1/2 of YZJ-1139、zolpidem
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
CL/F of YZJ-1139、zolpidem
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
CL/F is defined as the apparent oral clearance following administration of the drug
Vz/F of YZJ-1139、zolpidem
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
Vz/F is defined as the apparent volume of distribution of the drug
Left and right saccade peak velocity (SPV) of Eye Movements
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
Instruct the subject to fix their gaze on the red light spot on the LED display and move their eyes with the light spot. During the test, the head and body must remain still. The test consists of the following two parts, each lasting 2 minutes. Between the two parts, the subject should rest for a certain period of time based on their level of fatigue. Part 1: Scanning eye movements Part 2: Smooth pursuit eye movements.
left and right saccade accuracy rate (SacAcc) of Eye Movements
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
Instruct the subject to fix their gaze on the red light spot on the LED display and move their eyes with the light spot. During the test, the head and body must remain still. The test consists of the following two parts, each lasting 2 minutes. Between the two parts, the subject should rest for a certain period of time based on their level of fatigue. Part 1: Scanning eye movements Part 2: Smooth pursuit eye movements.
Left and right saccade eye movement response time (SacRT) of Eye Movements
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
Instruct the subject to fix their gaze on the red light spot on the LED display and move their eyes with the light spot. During the test, the head and body must remain still. The test consists of the following two parts, each lasting 2 minutes. Between the two parts, the subject should rest for a certain period of time based on their level of fatigue. Part 1: Scanning eye movements Part 2: Smooth pursuit eye movements.
Smooth eye movement to the left and right (Smooth) of Eye Movements
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
Instruct the subject to fix their gaze on the red light spot on the LED display and move their eyes with the light spot. During the test, the head and body must remain still. The test consists of the following two parts, each lasting 2 minutes. Between the two parts, the subject should rest for a certain period of time based on their level of fatigue. Part 1: Scanning eye movements Part 2: Smooth pursuit eye movements.
Body Sway
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
The subject takes off their shoes, spreads their feet shoulder-width apart, and stands on a flat ground 120 cm away from the measuring device. They close their eyes and stand for 2 minutes, and the test measures the body sway amplitude (mm) of the subject during the 2-minute closed-eye period. The test evaluates the subject's postural balance
Simple response time of Choice Reaction Time Test
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
The test lasts for 1 minute. During the test, there is a vertical line in the center of the screen. On both sides of the screen, random "left" or "right" words will appear. The participants are required to ignore the word meanings and click the "right" or "left" key based on the word's position.
Simple response accuracy rate of Choice Reaction Time Test
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
The test lasts for 1 minute. During the test, there is a vertical line in the center of the screen. On both sides of the screen, random "left" or "right" words will appear. The participants are required to ignore the word meanings and click the "right" or "left" key based on the word's position.
Selective response time of Choice Reaction Time Test
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
During the test, there was a dividing line in the middle of the screen. During the test, the word "left" or "right" appeared randomly on both sides of the screen. Subjects were asked to ignore the position of the word and click the key "right" or "left" according to the meaning of the word.
Selective response accuracy rate of Choice Reaction Time Test
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
During the test, there was a dividing line in the middle of the screen. During the test, the word "left" or "right" appeared randomly on both sides of the screen. Subjects were asked to ignore the position of the word and click the key "right" or "left" according to the meaning of the word.
The average reaction time for correct responses of Digit Symbol Substitution Test
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
The test time is not more than 2 minutes, the symbol is displayed on the screen, and the subject clicks the corresponding number according to the corresponding relationship between the symbol and the number given below. After clicking or exceeding the upper limit of the reaction time, the subject automatically enters the next symbol.
The number of correct responses of Digit Symbol Substitution Test
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
The test time is not more than 2 minutes, the symbol is displayed on the screen, and the subject clicks the corresponding number according to the corresponding relationship between the symbol and the number given below. After clicking or exceeding the upper limit of the reaction time, the subject automatically enters the next symbol.
The average reaction time for incorrect responses of Digit Symbol Substitution Test
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
The test time is not more than 2 minutes, the symbol is displayed on the screen, and the subject clicks the corresponding number according to the corresponding relationship between the symbol and the number given below. After clicking or exceeding the upper limit of the reaction time, the subject automatically enters the next symbol.
The number of incorrect responses of Digit Symbol Substitution Test
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
The test time is not more than 2 minutes, the symbol is displayed on the screen, and the subject clicks the corresponding number according to the corresponding relationship between the symbol and the number given below. After clicking or exceeding the upper limit of the reaction time, the subject automatically enters the next symbol.
The number of non-responses of Digit Symbol Substitution Test
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
The test time is not more than 2 minutes, the symbol is displayed on the screen, and the subject clicks the corresponding number according to the corresponding relationship between the symbol and the number given below. After clicking or exceeding the upper limit of the reaction time, the subject automatically enters the next symbol.
Immediate recall of Word Recall Test
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
About 1-2 hours after dosing， First, the subjects were shown 20 unrelated words, each word for a few seconds, and then the subjects were asked to immediately recall the words they just saw. The number of correct words in instantaneous recall was recorded respectively
Delayed recall of Word Recall Test
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
About 1-2 hours later, the subjects were allowed to freely recall the words again, which was delayed recall; The number of correct words in delayed recall was recorded respectively
Delayed recognition of Word Recall Test
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
The subjects were then presented with 40 words (of which 20 were previously presented words and 20 were confounding words), and were asked to answer one by one whether they were the words they had just seen. The number of correct words in delayed extraction was recorded respectively
1 secondary outcome
Adverse events (AEs)
Time frame: From Day 1 to Day 2 post single dose；up to 4 weeks
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 12 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 and Zolpidem in people with Insomnia, 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 4 inclusion and 18 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 12 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. Some participants in this study may receive a placebo. 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?
Cmax of YZJ-1139、zolpidem (time frame: From Day 1 to Day 2 post single dose；up to 4 weeks). The study lists 24 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 12 Nov 2024.