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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03662568

Enrollment

Registered

2018-09-07

Start date

2018-06-26

Completion date

2019-06-10

Last updated

2019-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

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.

Interventions

DRUGGLS4

Administered GLS4 120 mg orally three times daily in fed state

DRUGRTV

Administered RTV 100 mg orally three times daily in fed state

DRUGETV

Administered orally ETV 0.5 mg once daily in fasted state

DRUGTDF

Administered TDF 300 mg orally once daily in fasted state

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Adverse events	Baseline to day 23	To assess the safety and tolerability after dosing
AUC	Day 1-2 and Day 21-23	Area under the plasma concentration-time curve of study drugs
Tmax	Day 1-2 and Day 21-23	Time to maximum concentration of study drugs
T1/2	Day 1-2 and Day 21-23	Terminal half-life of study drugs
Cmax	Day 1-2 and Day 21-23	Maximum plasma concentration of study drugs

Secondary

Measure	Time frame	Description
Vz/F	Day 1-2 and Day 21-23	Apparent volume of distribution of study drugs
Cmin	Day 1-2 and Day 21-23	Minimum plasma concentration of study drugs
CL/F	Day 1-2 and Day 21-23	Apparent clearance of study drugs

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026