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Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HEC74647
HEC110114
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)MaleAccepts 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 3 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.
  • Known history of allergy to study drugs，or 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 Type

Experimental

Experimental

Arm Label

Part A

Part B

Arm Description

Subjects will receive HEC74647 on Day 1~7 and Day13~19, co-administration with HEC110114 on Day13~19.

Subjects will receive HEC110114 on Day 1~7 and Day13~19, co-administration with HEC74647 on Day13~19.

Outcomes

Primary Outcome Measures

Adverse Events
Incidence of adverse events
Cmax
Maximum plasma concentration of study drugs
AUC
Maximum plasma concentration of study drugs

Secondary Outcome Measures

Full Information

First Posted
January 14, 2020
Last Updated
November 4, 2020
Sponsor
Sunshine Lake Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04232514
Brief Title
Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects
Official Title
A Open-label, Single Center Drug Interaction Study Between HEC74647PA Capsule and HEC110114 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
August 10, 2020 (Actual)
Study Completion Date
August 22, 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
The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of HEC74647 combined with HEC110114 in healthy subjects
Detailed Description
This is a 2-part study with each part is an open-label study in healthy adult subjects. Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods of Day 1~7 and Day 13~19.

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
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A
Arm Type
Experimental
Arm Description
Subjects will receive HEC74647 on Day 1~7 and Day13~19, co-administration with HEC110114 on Day13~19.
Arm Title
Part B
Arm Type
Experimental
Arm Description
Subjects will receive HEC110114 on Day 1~7 and Day13~19, co-administration with HEC74647 on Day13~19.
Intervention Type
Drug
Intervention Name(s)
HEC74647
Intervention Description
Administered HEC74647 200 mg orally once daily in fed state
Intervention Type
Drug
Intervention Name(s)
HEC110114
Intervention Description
Administered HEC110114 800 mg orally once daily in fed state
Primary Outcome Measure Information:
Title
Adverse Events
Description
Incidence of adverse events
Time Frame
From Days 1-26
Title
Cmax
Description
Maximum plasma concentration of study drugs
Time Frame
Day 7-12 and Day 19-26
Title
AUC
Description
Maximum plasma concentration of study drugs
Time Frame
Day 7-12 and Day 19-26

10. Eligibility

Sex
Male
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 3 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. Known history of allergy to study drugs，or 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

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Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects

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