The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects

Insomnia Clinical Trial

Official title:

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC83518 Tablets in Chinses Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04596007
• Other study ID #: HEC83518-P-01 / CRC-C1934
• Status: Recruiting
• Phase: Phase 1
• Start date: April 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: October 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

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2021
• Est. primary completion date: September 10, 2020
• 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 Plann 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 has 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 positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.

2. 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.

3. Subjects with history of sleep-related illness.

4. Subjects with history of severe involuntary hypoglycemia

5. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.

6. 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.

7. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.

8. Positive results from urine drug screen test.

9. 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.

10. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.

11. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.

12. Subjects who plan to receive or have had organ transplants.

13. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.

14. Subjects who participated in another clinical trial within 3 months prior to initial dosing.

15. 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

Drug:
• HEC83518 tablets
Each dose of HEC83518 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
• Placebo
placebo

Locations

Country	Name	City	State
China	The Shanghai xuhui district 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	The pharmacodynamics of HEC83518 tablets	The pharmacodynamics of HEC83518 was preliminarily explored through KSS (Karolinska sleepiness Scale, Karolinska Sleepiness Scale) and sleep monitoring instrument	up to 24 hours
Primary	The Number of Adverse Events (AEs)	Safety and Tolerability of HEC83518 by Assessment of the Number of Adverse Events (AEs) Following Administration in Single Ascending Dose .	up to 5 days
Secondary	PK parameters - AUC0-8	area under the concentration versus time curve (AUC) from time zero to infinity	up to 96 hours
Secondary	PK parameters - Cmax	Geometric Mean of Maximum Observed Plasma Concentration of HEC83518	up to 96 hours
Secondary	PK parameters -tmax	time to peak	up to 96 hours
Secondary	PK parameters -t½	apparent terminal elimination half-life	up to 96 hours
Secondary	PK parameters -Vz/F	apparent volume of distribution	up to 96 hours
Secondary	PK parameters - MRT	the Mean Residence Time	up to 96 hours
Secondary	PK parameters -CL/F	the Apparent Clearance	up to 96 hours