the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04667429
• Other study ID #: HEC83518-P-02 / CRC-C2048
• Status: Recruiting
• Phase: Phase 1
• Start date: January 18, 2021
• Est. completion date: October 2021

Study information

• Verified date: December 2020
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: YanMei Liu, MS
• Phone: 021-54030254
• Email: ymliu[@]shxh-centerlab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: October 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• Food
HEC83518 40mg will be taken orally fasted or with food

Drug:
• HEC83518
HEC83518 will be taken orally before sleep for 15 days
• placebo
The placebo will be administered before sleep for 15 days.

Locations

Country	Name	City	State
China	The Shanghai Xuhui Central Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	up to 24 hour
Other	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)
Other	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)
Other	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)
Other	Sleep efficiency measured by a polysomnograph		during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)
Primary	Adverse event	To assess the safety and tolerability of therapy	up to 34 days
Secondary	Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-8 )		up to 72 hours
Secondary	Maximum Plasma Concentration ( Cmax)		up to 72 hours
Secondary	Time to peak(tmax)		up to 72 hours
Secondary	Apparent terminal elimination half-life(t½)		up to 72 hours
Secondary	Apparent volume of distribution(Vz/F)		up to 72 hours
Secondary	The Mean Residence Time#(MRT)		up to 72 hours
Secondary	The Apparent Clearance (CL/F)		up to 72 hours
Secondary	The Accumulation Ratio(R)		up to 60 hours
Secondary	Food Effect on the Cmax		up to 72 hours
Secondary	Food Effect on the AUC		up to 72 hours