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

Sunshine Lake Pharma

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: ETV; Drug: TDF; Drug: RTV; Drug: GLS4

Study type: Interventional

Funder types: Industry

Identifiers

NCT03662568

PCD-DGLS4-18-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 4 patient groups

Part A:Group A

Experimental group

Description:

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

Treatment:

Drug: GLS4

Drug: RTV

Drug: ETV

Part A:Group B

Experimental group

Description:

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

Treatment:

Drug: GLS4

Drug: RTV

Drug: ETV

Part B:Group C

Experimental group

Description:

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

Treatment:

Drug: GLS4

Drug: RTV

Drug: TDF

Part B:Group D

Experimental group

Description:

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

Treatment:

Drug: GLS4

Drug: RTV

Drug: TDF