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

NCT ID: NCT03662568

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-26
• Study Completion Date: 2019-06-10

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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A:Group A

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

Group Type: EXPERIMENTAL

GLS4

Intervention Type: DRUG

Administered GLS4 120 mg orally three times daily in fed state

RTV

Intervention Type: DRUG

Administered RTV 100 mg orally three times daily in fed state

ETV

Intervention Type: DRUG

Administered orally ETV 0.5 mg once daily in fasted state

Part A:Group B

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

Group Type: EXPERIMENTAL

GLS4

Intervention Type: DRUG

Administered GLS4 120 mg orally three times daily in fed state

RTV

Intervention Type: DRUG

Administered RTV 100 mg orally three times daily in fed state

ETV

Intervention Type: DRUG

Administered orally ETV 0.5 mg once daily in fasted state

Part B:Group C

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

Group Type: EXPERIMENTAL

GLS4

Intervention Type: DRUG

Administered GLS4 120 mg orally three times daily in fed state

RTV

Intervention Type: DRUG

Administered RTV 100 mg orally three times daily in fed state

TDF

Intervention Type: DRUG

Administered TDF 300 mg orally once daily in fasted state

Part B:Group D

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

Group Type: EXPERIMENTAL

GLS4

Intervention Type: DRUG

Administered GLS4 120 mg orally three times daily in fed state

RTV

Intervention Type: DRUG

Administered RTV 100 mg orally three times daily in fed state

TDF

Intervention Type: DRUG

Administered TDF 300 mg orally once daily in fasted state

Interventions

GLS4

Administered GLS4 120 mg orally three times daily in fed state

Intervention Type: DRUG

RTV

Administered RTV 100 mg orally three times daily in fed state

Intervention Type: DRUG

ETV

Administered orally ETV 0.5 mg once daily in fasted state

Intervention Type: DRUG

TDF

Administered TDF 300 mg orally once daily in fasted state

Intervention Type: DRUG

Other Intervention Names

Morphothiadine Mesilate Capsules; Ritonavir tablet; Entecavir table; Tenofovir Disoproxil Fumarate table

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanhua Ding, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

The First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

PCD-DGLS4-18-001

Identifier Type: -

Identifier Source: org_study_id