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

NCT ID: NCT04667429

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2021-10-31

Brief Summary

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

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Food effect

HEC83518 40mg will be administered fasted, or with high-fat meal for once.

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

HEC83518 40mg will be taken orally fasted or with food

Multiple Ascending Doses-HEC83518 20mg

HEC83518 20mg will be administered before sleep for 15 days .

Group Type: EXPERIMENTAL

HEC83518

Intervention Type: DRUG

HEC83518 will be taken orally before sleep for 15 days

Multiple Ascending Doses-HEC83518 40mg

HEC83518 40mg will be administered before sleep for 15 days .

Group Type: EXPERIMENTAL

HEC83518

Intervention Type: DRUG

HEC83518 will be taken orally before sleep for 15 days

Multiple Ascending Doses-HEC83518 80mg

HEC83518 80mg will be administered before sleep for 15 days .

Group Type: EXPERIMENTAL

HEC83518

Intervention Type: DRUG

HEC83518 will be taken orally before sleep for 15 days

Multiple Ascending Doses-placebo

Placebo will be administered before sleep for 15 days .

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

The placebo will be administered before sleep for 15 days.

Interventions

Food

HEC83518 40mg will be taken orally fasted or with food

Intervention Type: OTHER

HEC83518

HEC83518 will be taken orally before sleep for 15 days

Intervention Type: DRUG

placebo

The placebo will be administered before sleep for 15 days.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

YanMei Liu, MS

Role: CONTACT

ymliu@shxh-centerlab.com

021-54030254

Facility Contacts

YanMei Liu, MS

Role: primary

ymliu@shxh-centerlab.com

021-54030254

Other Identifiers

HEC83518-P-02 / CRC-C2048

Identifier Type: -

Identifier Source: org_study_id