Clinical trial NCT04667429: the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets
Official title: A Phase I,Double-Blind, Placebo-Controlled, Multiple Oral Dose, Safety, Tolerability, Pharmacokinetics and Food Effect Study of HEC83518 Tablets in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Insomnia
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Multiple Dose Safety, Tolerability, PK ，PD and Food Effect Study of HEC83518 in Healthy Subjects


Eligibility criteria: Inclusion Criteria:

1. Subjects who are willing and are able to provide a written informed consent to participate in the study.
2. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
3. Subjects aged between 18 and 45 (both inclusive) years old.
4. Healthy volunteers have a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening.
5. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

1. Subjects with a heart rate ≥100 beats per minute or ≤ 60 beats per minute at screening or baseline.
2. Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
3. Subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;Subjects with history of stroke, epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
4. Subjects with history of sleep-related illness.
5. Subjects with history of severe involuntary hypoglycemia
6. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
7. Use of any prescription or non-prescription medications within 14 days prior to initial dosing,or Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
8. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
9. Positive results from urine drug screen test.
10. History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of \> 21 units/week), or positive results from alcohol breath test.
11. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.
12. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
13. Subjects who plan to receive or have had organ transplants.
14. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential. 15 Subjects who participated in another clinical trial within 3 months prior to initial dosing.

16.Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.

Primary outcomes:
measure: Adverse event
timeFrame: up to 34 days
Secondary outcomes:
measure: Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ )
timeFrame: up to 72 hours
measure: Maximum Plasma Concentration ( Cmax)
timeFrame: up to 72 hours
measure: Time to peak(tmax)
timeFrame: up to 72 hours
measure: Apparent terminal elimination half-life(t½)
timeFrame: up to 72 hours
measure: Apparent volume of distribution(Vz/F)
timeFrame: up to 72 hours
measure: The Mean Residence Time#(MRT)
timeFrame: up to 72 hours
measure: The Apparent Clearance (CL/F)
timeFrame: up to 72 hours
measure: The Accumulation Ratio(R)
timeFrame: up to 60 hours
measure: Food Effect on the Cmax
timeFrame: up to 72 hours
measure: Food Effect on the AUC
timeFrame: up to 72 hours
Other outcomes:
measure: Karolinska sleepiness Scale（KSS）
timeFrame: up to 24 hour
measure: Latency to sleep measured by a polysomnograph
timeFrame: during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)
measure: Wake After Sleep Onset measured by a polysomnograph
timeFrame: during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)
measure: Total sleep time measured by a polysomnograph
timeFrame: during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)
measure: Sleep efficiency measured by a polysomnograph
timeFrame: during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)
Locations:
city: Shanghai
country: China
facility: The Shanghai Xuhui Central Hospital
state: Shanghai
Study officials:
References: