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

NCT03662568 | Completed Phase 1

• 1 other identifier: PCD-DGLS4-18-001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (5)

• Cmax

  Maximum plasma concentration of study drugs

  Day 1-2 and Day 21-23

• AUC

  Area under the plasma concentration-time curve of study drugs

  Day 1-2 and Day 21-23

• Tmax

  Time to maximum concentration of study drugs

  Day 1-2 and Day 21-23

• T1/2

  Terminal half-life of study drugs

  Day 1-2 and Day 21-23

• Adverse events

  To assess the safety and tolerability after dosing

  Baseline to day 23

Secondary Outcomes (3)

• CL/F

  Day 1-2 and Day 21-23

• Vz/F

  Day 1-2 and Day 21-23

• Cmin

  Day 1-2 and Day 21-23

Study Arms (4)

Part A:Group A

EXPERIMENTAL

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

Drug: GLS4; Drug: RTV; Drug: ETV

Part A:Group B

EXPERIMENTAL

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

Drug: GLS4; Drug: RTV; Drug: ETV

Part B:Group C

EXPERIMENTAL

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

Drug: GLS4; Drug: RTV; Drug: TDF

Part B:Group D

EXPERIMENTAL

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

Drug: GLS4; Drug: RTV; Drug: TDF

Interventions

GLS4 DRUG

Administered GLS4 120 mg orally three times daily in fed state

Also known as: Morphothiadine Mesilate Capsules

Part A:Group A; Part A:Group B; Part B:Group C; Part B:Group D

RTV DRUG

Administered RTV 100 mg orally three times daily in fed state

Also known as: Ritonavir tablet

Part A:Group A; Part A:Group B; Part B:Group C; Part B:Group D

ETV DRUG

Administered orally ETV 0.5 mg once daily in fasted state

Also known as: Entecavir table

Part A:Group A; Part A:Group B

TDF DRUG

Administered TDF 300 mg orally once daily in fasted state

Also known as: Tenofovir Disoproxil Fumarate table

Part B:Group C; Part B:Group D

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Ritonavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yanhua Ding, Doctor

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: June 26, 2018
• Primary Completion: July 31, 2018
• Study Completion: June 10, 2019
• Last Updated: October 9, 2019

Record last verified: 2018-09

Locations

CN (1)