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

NCT04667429 | Completed Phase 1

• 1 other identifier: HEC83518-P-02 / CRC-C2048
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Adverse event

  To assess the safety and tolerability of therapy

  up to 34 days

Secondary Outcomes (10)

• 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

• 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

Other Outcomes (5)

• Karolinska sleepiness Scale（KSS）

  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)

Study Arms (5)

Food effect

EXPERIMENTAL

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

Other: Food

Multiple Ascending Doses-HEC83518 20mg

EXPERIMENTAL

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

Drug: HEC83518

Multiple Ascending Doses-HEC83518 40mg

EXPERIMENTAL

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

Drug: HEC83518

Multiple Ascending Doses-HEC83518 80mg

EXPERIMENTAL

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

Drug: HEC83518

Multiple Ascending Doses-placebo

PLACEBO COMPARATOR

Placebo will be administered before sleep for 15 days .

Drug: placebo

Interventions

Food OTHER

HEC83518 40mg will be taken orally fasted or with food

Food effect

HEC83518 DRUG

HEC83518 will be taken orally before sleep for 15 days

Multiple Ascending Doses-HEC83518 20mg; Multiple Ascending Doses-HEC83518 40mg; Multiple Ascending Doses-HEC83518 80mg

placebo DRUG

The placebo will be administered before sleep for 15 days.

Multiple Ascending Doses-placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who are willing and are able to provide a written informed consent to participate in the study.
• Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
• Subjects aged between 18 and 45 (both inclusive) years old.
• 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.
• 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).

You may not qualify if:

• Subjects with a heart rate ≥100 beats per minute or ≤ 60 beats per minute at screening or baseline.
• 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.
• 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.
• Subjects with history of sleep-related illness.
• Subjects with history of severe involuntary hypoglycemia
• Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
• 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.
• Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
• Positive results from urine drug screen test.
• 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.
• Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.
• Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
• Subjects who plan to receive or have had organ transplants.
• 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.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

The Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Food

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Ascending Multiple Dose Study is Double-blind design; Food Effect Study is open-label design.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 14, 2020
• Study Start: January 18, 2021
• Primary Completion: July 9, 2021
• Study Completion: July 9, 2021
• Last Updated: May 1, 2026

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)