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Multiple Dose Safety, Tolerability, PK ,PD and Food Effect Study of HEC83518 in Healthy Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Food effect | Experimental | HEC83518 40mg will be administered fasted, or with high-fat meal for once. |
|
| Multiple Ascending Doses-HEC83518 20mg | Experimental | HEC83518 20mg will be administered before sleep for 15 days . |
|
| Multiple Ascending Doses-HEC83518 40mg | Experimental | HEC83518 40mg will be administered before sleep for 15 days . |
|
| Multiple Ascending Doses-HEC83518 80mg | Experimental | HEC83518 80mg will be administered before sleep for 15 days . |
|
| Multiple Ascending Doses-placebo | Placebo Comparator | Placebo will be administered before sleep for 15 days . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food | Other | HEC83518 40mg will be taken orally fasted or with food |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | To assess the safety and tolerability of therapy | up to 34 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ ) | up to 72 hours | |
| Maximum Plasma Concentration ( Cmax) | up to 72 hours | |
| Measure | Description | Time Frame |
|---|---|---|
| Karolinska sleepiness Scale(KSS) | This is a 9-point scale (1 = extremely alert, 3 = alert, 5 = neither alert nor sleepy,7 = sleepy - but no difficulty remaining awake,and 9 = extremely sleepy - fighting sleep).The score of KSS scale will be recorded at different time and the change score compared with baseline will be analysed to evaluated the start of effective time, the most effective time and the recovered time to baseline. |
Inclusion Criteria:
Exclusion Criteria:
16.Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Ascending Multiple Dose Study is Double-blind design; Food Effect Study is open-label design.
| HEC83518 |
| Drug |
HEC83518 will be taken orally before sleep for 15 days |
|
| placebo | Drug | The placebo will be administered before sleep for 15 days. |
|
| Time to peak(tmax) |
| up to 72 hours |
| Apparent terminal elimination half-life(t½) | up to 72 hours |
| Apparent volume of distribution(Vz/F) | up to 72 hours |
| The Mean Residence Time#(MRT) | up to 72 hours |
| The Apparent Clearance (CL/F) | up to 72 hours |
| The Accumulation Ratio(R) | up to 60 hours |
| Food Effect on the Cmax | up to 72 hours |
| Food Effect on the AUC | up to 72 hours |
| up to 24 hour |
| Latency to sleep measured by a polysomnograph | during the sleep time on the night(from 22:00-22:30 to the next morning wake-up) |
| Wake After Sleep Onset measured by a polysomnograph | during the sleep time on the night(from 22:00-22:30 to the next morning wake-up) |
| Total sleep time measured by a polysomnograph | during the sleep time on the night(from 22:00-22:30 to the next morning wake-up) |
| Sleep efficiency measured by a polysomnograph | during the sleep time on the night(from 22:00-22:30 to the next morning wake-up) |
| D001523 |
| Mental Disorders |