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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662568
• Other study ID #: PCD-DGLS4-18-001
• Status: Completed
• Phase: Phase 1
• Start date: June 26, 2018
• Est. completion date: June 10, 2019

Study information

• Verified date: September 2018
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 10, 2019
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• GLS4
Administered GLS4 120 mg orally three times daily in fed state
• RTV
Administered RTV 100 mg orally three times daily in fed state
• ETV
Administered orally ETV 0.5 mg once daily in fasted state
• TDF
Administered TDF 300 mg orally once daily in fasted state

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum plasma concentration of study drugs	Day 1-2 and Day 21-23
Primary	AUC	Area under the plasma concentration-time curve of study drugs	Day 1-2 and Day 21-23
Primary	Tmax	Time to maximum concentration of study drugs	Day 1-2 and Day 21-23
Primary	T1/2	Terminal half-life of study drugs	Day 1-2 and Day 21-23
Primary	Adverse events	To assess the safety and tolerability after dosing	Baseline to day 23
Secondary	CL/F	Apparent clearance of study drugs	Day 1-2 and Day 21-23
Secondary	Vz/F	Apparent volume of distribution of study drugs	Day 1-2 and Day 21-23
Secondary	Cmin	Minimum plasma concentration of study drugs	Day 1-2 and Day 21-23