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COMPLETEDPHASE1

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

NCT03662568•Sunshine Lake Pharma Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

MALE

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.

Locations (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Key Dates

Start Date

June 26, 2018

Primary Completion Date

July 31, 2018

Completion Date

June 10, 2019

Last Updated

October 9, 2019

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis B

Interventions

GLS4

DRUG

RTV

DRUG

ETV

DRUG

TDF

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

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