the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets
- Registration Number
- NCT04667429
- Lead Sponsor
- Sunshine Lake Pharma Co., Ltd.
- Brief Summary
Multiple Dose Safety, Tolerability, PK ，PD and Food Effect Study of HEC83518 in Healthy Subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 52
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Food effect Food HEC83518 40mg will be administered fasted, or with high-fat meal for once. Multiple Ascending Doses-placebo placebo Placebo will be administered before sleep for 15 days . Multiple Ascending Doses-HEC83518 40mg HEC83518 HEC83518 40mg will be administered before sleep for 15 days . Multiple Ascending Doses-HEC83518 80mg HEC83518 HEC83518 80mg will be administered before sleep for 15 days . Multiple Ascending Doses-HEC83518 20mg HEC83518 HEC83518 20mg will be administered before sleep for 15 days .
- Primary Outcome Measures
Name Time Method Adverse event up to 34 days To assess the safety and tolerability of therapy
- Secondary Outcome Measures
Name Time Method Time to peak(tmax) up to 72 hours The Apparent Clearance (CL/F) up to 72 hours Food Effect on the AUC up to 72 hours Maximum Plasma Concentration ( Cmax) up to 72 hours Food Effect on the Cmax up to 72 hours The Mean Residence Time#(MRT) up to 72 hours The Accumulation Ratio(R) up to 60 hours Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ ) up to 72 hours Apparent volume of distribution(Vz/F) up to 72 hours Apparent terminal elimination half-life(t½) up to 72 hours
Trial Locations
- Locations (1)
The Shanghai Xuhui Central Hospital
🇨🇳Shanghai, Shanghai, China