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The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC110114 Tablets in HCV-infected Subjects (HEC110114)

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HEC110114 Tablet
Sofosbuvir 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 - 65 Years (Adult, Older Adult)All SexesDoes not accept 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 65 years of age inclusive;
  • Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive, and a body weight ≥50 kg for males and ≥45 kg for females;
  • No previous treatment with any direct-acting antiviral (DAA) drugs for HCV, such as Simeprevir, Sofosbuvir, Daclatasvir etc;
  • HCV RNA ≥10*5 IU/mL at screening (Roche COBAS Taqman);
  • Chronic genotype 1-6 HCV Infection, multiple genotypes, subtype unidentifiable or others ;
  • Serum ALT ≤5 times ULN.

Exclusion Criteria:

  • 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;
  • History of any non-HCV liver diseases, including but not limited to hemochromatosis, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis, drug or alcoholic hepatitis, non-alcoholic steatohepatitis, etc;
  • 12-lead ECG with clinically significant;
  • Pregnant or lactating women;
  • Creatinine clearance < 60 mL/min;
  • 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 Type

Experimental

Experimental

Experimental

Arm Label

600 mg multiple doses

800 mg multiple doses

1200 mg multiple doses

Arm Description

Subjects receiving 600 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days

Subjects receiving 800 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days

Subjects receiving 1200 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days

Outcomes

Primary Outcome Measures

Adverse Events
Incidence of adverse events

Secondary Outcome Measures

Cmax
Maximum Observed Plasma Concentration
Tmax
Time to Maximum Observed Plasma Concentration
T1/2 T1/2 T1/2 T1/2
Apparent Half-Life
AUClast
Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration
HCV RNA
HCV RNA declined from baseline

Full Information

First Posted
December 16, 2019
Last Updated
September 9, 2020
Sponsor
Sunshine Lake Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04202952
Brief Title
The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC110114 Tablets in HCV-infected Subjects
Acronym
HEC110114
Official Title
A Phase Ib/IIa, Single Center, Randomized, Open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability， Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
August 27, 2020 (Actual)
Study Completion Date
August 27, 2020 (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 Ib/IIa, Single Center, Randomized, open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability，Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects
Detailed Description
A total of 24 evaluable patients will be enrolled in this study. The study randomly divided into three dose groups and HEC110114 tablets planned dose levels are 600, 800, and 1200 mg, sofosbuvir tablets planned dose levels are 400 mg .

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, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
600 mg multiple doses
Arm Type
Experimental
Arm Description
Subjects receiving 600 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days
Arm Title
800 mg multiple doses
Arm Type
Experimental
Arm Description
Subjects receiving 800 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days
Arm Title
1200 mg multiple doses
Arm Type
Experimental
Arm Description
Subjects receiving 1200 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days
Intervention Type
Drug
Intervention Name(s)
HEC110114 Tablet
Intervention Description
administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir Tablet
Intervention Description
administered orally once daily
Primary Outcome Measure Information:
Title
Adverse Events
Description
Incidence of adverse events
Time Frame
From Days 1-10
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum Observed Plasma Concentration
Time Frame
At pre-defined intervals from Days 1-7
Title
Tmax
Description
Time to Maximum Observed Plasma Concentration
Time Frame
At pre-defined intervals from Days 1-7
Title
T1/2 T1/2 T1/2 T1/2
Description
Apparent Half-Life
Time Frame
At pre-defined intervals from Days 1-7
Title
AUClast
Description
Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration
Time Frame
At pre-defined intervals from Days 1-7
Title
HCV RNA
Description
HCV RNA declined from baseline
Time Frame
At pre-defined intervals from Days 1-10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 65 years of age inclusive; Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive, and a body weight ≥50 kg for males and ≥45 kg for females; No previous treatment with any direct-acting antiviral (DAA) drugs for HCV, such as Simeprevir, Sofosbuvir, Daclatasvir etc; HCV RNA ≥10*5 IU/mL at screening (Roche COBAS Taqman); Chronic genotype 1-6 HCV Infection, multiple genotypes, subtype unidentifiable or others ; Serum ALT ≤5 times ULN. Exclusion Criteria: 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; History of any non-HCV liver diseases, including but not limited to hemochromatosis, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis, drug or alcoholic hepatitis, non-alcoholic steatohepatitis, etc; 12-lead ECG with clinically significant; Pregnant or lactating women; Creatinine clearance < 60 mL/min; Subjects deemed unsuitable by the investigator for any other reason.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junqi Niu, Doctor
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
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
Jilin
State/Province
Changchun
ZIP/Postal Code
130021
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC110114 Tablets in HCV-infected Subjects

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