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The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects (HEC110114)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903081
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sunshine Lake Pharma Co., Ltd.

Tracking Information
First Submitted Date  ICMJE April 3, 2019
First Posted Date  ICMJE April 4, 2019
Last Update Posted Date March 18, 2020
Actual Study Start Date  ICMJE March 6, 2019
Actual Primary Completion Date October 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
Adverse Events [ Time Frame: From Days 1-12 ]
Percentage of Participants with Adverse Events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
  • Cmax [ Time Frame: At pre-defined intervals from Days 1-12 ]
    Maximum Observed Plasma Concentration
  • Tmax [ Time Frame: At pre-defined intervals from Days 1-12 ]
    Time to Maximum Observed Plasma Concentration
  • AUClast [ Time Frame: At pre-defined intervals from Days 1-12 ]
    Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration
  • AUC0-∞ [ Time Frame: At pre-defined intervals from Days 1-12 ]
    Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity
  • T1/2 [ Time Frame: At pre-defined intervals from Days 1-12 ]
    Apparent Half-Life
  • CL/F [ Time Frame: At pre-defined intervals from Days 1-12 ]
    Clearance (CL/F) of HEC110114
  • Cmin [ Time Frame: At pre-defined intervals from Days 1-11 for MAD ]
    Trough Plasma Concentration of HEC110114
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects
Official Title  ICMJE A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects
Brief Summary A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE
  • Drug: HEC110114 tablet
    administered orally once daily
  • Drug: Placebo Oral Tablet
    Placebo will be administered orally at a dose and frequency matched to HEC110114
Study Arms  ICMJE
  • Experimental: 100 mg single dose
    It includes two groups, one group is pilot study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=2) . Another group is formal study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=8) or matching placebo (N=2)
    Interventions:
    • Drug: HEC110114 tablet
    • Drug: Placebo Oral Tablet
  • Experimental: 300 mg single dose
    Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2)
    Interventions:
    • Drug: HEC110114 tablet
    • Drug: Placebo Oral Tablet
  • Experimental: 600 mg single dose
    Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2)
    Interventions:
    • Drug: HEC110114 tablet
    • Drug: Placebo Oral Tablet
  • Experimental: 800 mg single dose
    Healthy subjects, receiving a single dose of 800 mg HEC110114 tablet (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study
    Interventions:
    • Drug: HEC110114 tablet
    • Drug: Placebo Oral Tablet
  • Experimental: 1000 mg single dose
    Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2)
    Interventions:
    • Drug: HEC110114 tablet
    • Drug: Placebo Oral Tablet
  • Experimental: 1200 mg single dose
    Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2)
    Interventions:
    • Drug: HEC110114 tablet
    • Drug: Placebo Oral Tablet
  • Experimental: 1600 mg single dose
    Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2)
    Interventions:
    • Drug: HEC110114 tablet
    • Drug: Placebo Oral Tablet
  • Experimental: 600 mg multiple doses
    Healthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
    Interventions:
    • Drug: HEC110114 tablet
    • Drug: Placebo Oral Tablet
  • Experimental: 800 mg multiple doses
    Healthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
    Interventions:
    • Drug: HEC110114 tablet
    • Drug: Placebo Oral Tablet
  • Experimental: 1000 mg multiple doses
    Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
    Interventions:
    • Drug: HEC110114 tablet
    • Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2020)
93
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2019)
116
Actual Study Completion Date  ICMJE October 29, 2019
Actual Primary Completion Date October 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions
  • Be able to complete the study according to the trail protocol
  • Subjects (including partners) have no pregnancy plan within six months after the last dose of study drug and voluntarily take effective contraceptive measures
  • Male subjects and must be 18 to 45 years of age inclusive
  • Body weight ≥ 50 kg and body mass index(BMI)between 18 and 28 kg/m2, inclusive
  • Physical examination and vital signs without clinically significant abnormalities.

Exclusion Criteria:

  • Use of >5 cigarettes per day during the past 3 months
  • Allergies constitution ( multiple drug and food allergies)
  • History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine)
  • Donation or loss of blood over 450 mL within 3 months prior to screening
  • 12-lead ECG with clinically significant
  • Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis
  • Subjects deemed unsuitable by the investigator for any other reason.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03903081
Other Study ID Numbers  ICMJE HEC110114-P-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunshine Lake Pharma Co., Ltd.
Study Sponsor  ICMJE Sunshine Lake Pharma Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yanhua Ding, Doctor First Hospital of Jilin University
PRS Account Sunshine Lake Pharma Co., Ltd.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP