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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HEC110114 tablet
Placebo Oral Tablet
Sponsored by
Sunshine Lake Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

100 mg single dose

300 mg single dose

600 mg single dose

800 mg single dose

1000 mg single dose

1200 mg single dose

1600 mg single dose

600 mg multiple doses

800 mg multiple doses

1000 mg multiple doses

Arm Description

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)

Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2)

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

Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Healthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days

Healthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days

Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days

Outcomes

Primary Outcome Measures

Adverse Events
Percentage of Participants with Adverse Events

Secondary Outcome Measures

Cmax
Maximum Observed Plasma Concentration
Tmax
Time to Maximum Observed Plasma Concentration
AUClast
Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration
AUC0-∞
Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity
T1/2
Apparent Half-Life
CL/F
Clearance (CL/F) of HEC110114
Cmin
Trough Plasma Concentration of HEC110114

Full Information

First Posted
April 3, 2019
Last Updated
March 16, 2020
Sponsor
Sunshine Lake Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03903081
Brief Title
The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects
Acronym
HEC110114
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
October 29, 2019 (Actual)
Study Completion Date
October 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Lake Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
100 mg single dose
Arm Type
Experimental
Arm Description
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)
Arm Title
300 mg single dose
Arm Type
Experimental
Arm Description
Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2)
Arm Title
600 mg single dose
Arm Type
Experimental
Arm Description
Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2)
Arm Title
800 mg single dose
Arm Type
Experimental
Arm Description
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
Arm Title
1000 mg single dose
Arm Type
Experimental
Arm Description
Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2)
Arm Title
1200 mg single dose
Arm Type
Experimental
Arm Description
Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2)
Arm Title
1600 mg single dose
Arm Type
Experimental
Arm Description
Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2)
Arm Title
600 mg multiple doses
Arm Type
Experimental
Arm Description
Healthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
Arm Title
800 mg multiple doses
Arm Type
Experimental
Arm Description
Healthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
Arm Title
1000 mg multiple doses
Arm Type
Experimental
Arm Description
Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
Intervention Type
Drug
Intervention Name(s)
HEC110114 tablet
Intervention Description
administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo will be administered orally at a dose and frequency matched to HEC110114
Primary Outcome Measure Information:
Title
Adverse Events
Description
Percentage of Participants with Adverse Events
Time Frame
From Days 1-12
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum Observed Plasma Concentration
Time Frame
At pre-defined intervals from Days 1-12
Title
Tmax
Description
Time to Maximum Observed Plasma Concentration
Time Frame
At pre-defined intervals from Days 1-12
Title
AUClast
Description
Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration
Time Frame
At pre-defined intervals from Days 1-12
Title
AUC0-∞
Description
Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity
Time Frame
At pre-defined intervals from Days 1-12
Title
T1/2
Description
Apparent Half-Life
Time Frame
At pre-defined intervals from Days 1-12
Title
CL/F
Description
Clearance (CL/F) of HEC110114
Time Frame
At pre-defined intervals from Days 1-12
Title
Cmin
Description
Trough Plasma Concentration of HEC110114
Time Frame
At pre-defined intervals from Days 1-11 for MAD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanhua Ding, Doctor
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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