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OpenTrials
Completed

NCT Number: NCT04623814

the Safety, Tolerability, and Pharmacokinetics Study of HEC113995

Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC113995 PA•H2O in Healthy Subjects

Completed

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui Central Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

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

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 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 epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
  • 3. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
  • 4. 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.
  • 5. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
  • 6. Positive results from urine drug screen test.
  • 7. 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.
  • 8. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.
  • 9. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
  • 10. Subjects who plan to receive or have had organ transplants.
  • 11. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
  • 12. Subjects who participated in another clinical trial within 3 months prior to initial dosing.
  • 13. 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

HEC113995 20mg will be taken orally fasted or with food

HEC113995

Drug

HEC113995 will be taken orally fasted (HEC113995 10mg)or with food (HEC113995 20mg and 40mg) for 10 days

Placebo

Drug

The placebo will be administered fasted or with food for 10 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 120 hours

  2. Maximum Plasma Concentration ( Cmax)

    Time frame: up to 120 hours

  3. Time to peak(tmax)

    Time frame: up to 120 hours

  4. Apparent terminal elimination half-life(t½)

    Time frame: up to 120 hours

  5. Apparent volume of distribution(Vz/F)

    Time frame: up to 120 hours

  6. The Mean Residence Time( MRT)

    Time frame: up to 120 hours

  7. The Apparent Clearance (CL/F)

    Time frame: up to 120 hours

  8. The Accumulation Ratio(R)

    Time frame: up to 120 hours

  9. Food Effect on the Cmax

    Time frame: up to 120 hours

  10. Food Effect on the AUC

    Time frame: up to 120 hours

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study title

HEC113995-A Phase I,Double-Blind, Placebo-Controlled, Multiple Oral Dose, Safety, Tolerability, Pharmacokinetics and Food Effect Study in Healthy Chinese Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 10, 2020
Registry last updated
Nov 25, 2020

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.

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