Clinical trial NCT03662568: A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects
Official title: A Open-label, Single Center Drug Interaction Study of Morphothiadine Mesilate/Ritonavir , Entecavir and Tenofovir Disoproxil Fumarate in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-07
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax
timeFrame: Day 1-2 and Day 21-23
measure: AUC
timeFrame: Day 1-2 and Day 21-23
measure: Tmax
timeFrame: Day 1-2 and Day 21-23
measure: T1/2
timeFrame: Day 1-2 and Day 21-23
measure: Adverse events
timeFrame: Baseline to day 23
Secondary outcomes:
measure: CL/F
timeFrame: Day 1-2 and Day 21-23
measure: Vz/F
timeFrame: Day 1-2 and Day 21-23
measure: Cmin
timeFrame: Day 1-2 and Day 21-23
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Yanhua Ding, Doctor
role: PRINCIPAL_INVESTIGATOR
References: