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A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects

Primary Purpose

Chronic Hepatitis B

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

GLS4

RTV

ETV

TDF

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

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 1 year 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 3

Arm 4

Arm Type

Experimental

Arm Label

Part A:Group A

Part A:Group B

Part B:Group C

Part B:Group D

Arm Description

Subjects will receive GLS4+RTV on Day 1,followed by ETV on Day11-21 and co-administration with GLS4+RTV on Day 21.

Subjects will receive ETV on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with ETV on Day 21.

Subjects will receive GLS4+RTV on Day 1,followed by TDF on Day11-21 and co-administration with GLS4+RTV on Day 21.

Subjects will receive TDF on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with TDF on Day 21.

Outcomes

Primary Outcome Measures

Cmax

Maximum plasma concentration of study drugs

AUC

Area under the plasma concentration-time curve of study drugs

Tmax

Time to maximum concentration of study drugs

T1/2

Terminal half-life of study drugs

Adverse events

To assess the safety and tolerability after dosing

Secondary Outcome Measures

CL/F

Apparent clearance of study drugs

Vz/F

Apparent volume of distribution of study drugs

Cmin

Minimum plasma concentration of study drugs

Full Information

NCT ID

NCT03662568

First Posted

September 5, 2018

Last Updated

October 8, 2019

Sponsor

Sunshine Lake Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03662568

Brief Title

A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects

Official Title

A Open-label, Single Center Drug Interaction Study of Morphothiadine Mesilate/Ritonavir , Entecavir and Tenofovir Disoproxil Fumarate in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

June 26, 2018 (Actual)

Primary Completion Date

July 31, 2018 (Actual)

Study Completion Date

June 10, 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of Morphothiadine Mesilate/Ritonavir combined with Entecavir or Tenofovir Disoproxil Fumarate in healthy subjects

Detailed Description

This is a 2-part study with each part is an open-label, crossover study in healthy adult subjects. Total 56 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 28 subjects in each part. Part A is to evaluate the drug-interaction between GLS4/RTV and ETV, Part B is to evaluate the drug-interaction between GLS4/RTV and TDF. With each part, the subject will be split into two groups and receive study drug per the defined treatment periods of Day 1, Day 11-20 and Day 21.

6. Conditions and Keywords

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

Chronic Hepatitis B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A:Group A

Arm Type

Experimental

Arm Description

Subjects will receive GLS4+RTV on Day 1,followed by ETV on Day11-21 and co-administration with GLS4+RTV on Day 21.

Arm Title

Part A:Group B

Arm Type

Experimental

Arm Description

Subjects will receive ETV on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with ETV on Day 21.

Arm Title

Part B:Group C

Arm Type

Experimental

Arm Description

Subjects will receive GLS4+RTV on Day 1,followed by TDF on Day11-21 and co-administration with GLS4+RTV on Day 21.

Arm Title

Part B:Group D

Arm Type

Experimental

Arm Description

Subjects will receive TDF on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with TDF on Day 21.

Intervention Type

Drug

Intervention Name(s)

GLS4

Other Intervention Name(s)

Morphothiadine Mesilate Capsules

Intervention Description

Administered GLS4 120 mg orally three times daily in fed state

Intervention Type

Drug

Intervention Name(s)

RTV

Other Intervention Name(s)

Ritonavir tablet

Intervention Description

Administered RTV 100 mg orally three times daily in fed state

Intervention Type

Drug

Intervention Name(s)

ETV

Other Intervention Name(s)

Entecavir table

Intervention Description

Administered orally ETV 0.5 mg once daily in fasted state

Intervention Type

Drug

Intervention Name(s)

TDF

Other Intervention Name(s)

Tenofovir Disoproxil Fumarate table

Intervention Description

Administered TDF 300 mg orally once daily in fasted state

Primary Outcome Measure Information:

Title

Cmax

Description

Maximum plasma concentration of study drugs

Time Frame

Day 1-2 and Day 21-23

Title

AUC

Description

Area under the plasma concentration-time curve of study drugs

Time Frame

Day 1-2 and Day 21-23

Title

Tmax

Description

Time to maximum concentration of study drugs

Time Frame

Day 1-2 and Day 21-23

Title

T1/2

Description

Terminal half-life of study drugs

Time Frame

Day 1-2 and Day 21-23

Title

Adverse events

Description

To assess the safety and tolerability after dosing

Time Frame

Baseline to day 23

Secondary Outcome Measure Information:

Title

CL/F

Description

Apparent clearance of study drugs

Time Frame

Day 1-2 and Day 21-23

Title

Vz/F

Description

Apparent volume of distribution of study drugs

Time Frame

Day 1-2 and Day 21-23

Title

Cmin

Description

Minimum plasma concentration of study drugs

Time Frame

Day 1-2 and Day 21-23

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

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 1 year 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

Learn more about this trial

A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects

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