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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.

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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: HEC110114 tablet Drug: Placebo Oral Tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 6, 2019
Actual Primary Completion Date : October 29, 2019
Actual Study Completion Date : October 29, 2019

Arm Intervention/treatment
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)
Drug: HEC110114 tablet
administered orally once daily

Drug: Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114

Experimental: 300 mg single dose
Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2)
Drug: HEC110114 tablet
administered orally once daily

Drug: Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114

Experimental: 600 mg single dose
Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2)
Drug: HEC110114 tablet
administered orally once daily

Drug: Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114

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
Drug: HEC110114 tablet
administered orally once daily

Drug: Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114

Experimental: 1000 mg single dose
Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2)
Drug: HEC110114 tablet
administered orally once daily

Drug: Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114

Experimental: 1200 mg single dose
Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2)
Drug: HEC110114 tablet
administered orally once daily

Drug: Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114

Experimental: 1600 mg single dose
Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2)
Drug: HEC110114 tablet
administered orally once daily

Drug: Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114

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
Drug: HEC110114 tablet
administered orally once daily

Drug: Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114

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
Drug: HEC110114 tablet
administered orally once daily

Drug: Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114

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
Drug: HEC110114 tablet
administered orally once daily

Drug: Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: From Days 1-12 ]
    Percentage of Participants with Adverse Events


Secondary Outcome Measures :
  1. Cmax [ Time Frame: At pre-defined intervals from Days 1-12 ]
    Maximum Observed Plasma Concentration

  2. Tmax [ Time Frame: At pre-defined intervals from Days 1-12 ]
    Time to Maximum Observed Plasma Concentration

  3. AUClast [ Time Frame: At pre-defined intervals from Days 1-12 ]
    Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration

  4. AUC0-∞ [ Time Frame: At pre-defined intervals from Days 1-12 ]
    Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity

  5. T1/2 [ Time Frame: At pre-defined intervals from Days 1-12 ]
    Apparent Half-Life

  6. CL/F [ Time Frame: At pre-defined intervals from Days 1-12 ]
    Clearance (CL/F) of HEC110114

  7. Cmin [ Time Frame: At pre-defined intervals from Days 1-11 for MAD ]
    Trough Plasma Concentration of HEC110114



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903081


Locations
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China, Jilin
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Sponsors and Collaborators
Sunshine Lake Pharma Co., Ltd.
Investigators
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Principal Investigator: Yanhua Ding, Doctor First Hospital of Jilin University
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Responsible Party: Sunshine Lake Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT03903081    
Other Study ID Numbers: HEC110114-P-01
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic