Skip to main content
OpenTrials
Completed

NCT Number: NCT04667429

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

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

Treatment and study plan

Food

Other

HEC83518 40mg will be taken orally fasted or with food

HEC83518

Drug

HEC83518 will be taken orally before sleep for 15 days

Placebo

Drug

The placebo will be administered before sleep for 15 days.

Primary outcomes

  1. Adverse event

    Time frame: up to 34 days

    To assess the safety and tolerability of therapy

Secondary outcomes

  1. Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ )

    Time frame: up to 72 hours

  2. Maximum Plasma Concentration ( Cmax)

    Time frame: up to 72 hours

  3. Time to peak(tmax)

    Time frame: up to 72 hours

  4. Apparent terminal elimination half-life(t½)

    Time frame: up to 72 hours

  5. Apparent volume of distribution(Vz/F)

    Time frame: up to 72 hours

  6. The Mean Residence Time#(MRT)

    Time frame: up to 72 hours

  7. The Apparent Clearance (CL/F)

    Time frame: up to 72 hours

  8. The Accumulation Ratio(R)

    Time frame: up to 60 hours

  9. Food Effect on the Cmax

    Time frame: up to 72 hours

  10. Food Effect on the AUC

    Time frame: up to 72 hours

Other outcomes

  1. Karolinska sleepiness Scale(KSS)

    Time frame: up to 24 hour

    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.

  2. Latency to sleep measured by a polysomnograph

    Time frame: during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)

  3. Wake After Sleep Onset measured by a polysomnograph

    Time frame: during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)

  4. Total sleep time measured by a polysomnograph

    Time frame: during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)

  5. Sleep efficiency measured by a polysomnograph

    Time frame: during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 14, 2020
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.