A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects
- Registration Number
- NCT03662568
- Lead Sponsor
- Sunshine Lake Pharma Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 56
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part A:Group A GLS4 Subjects will receive GLS4+RTV on Day 1,followed by ETV on Day11-21 and co-administration with GLS4+RTV on Day 21. Part B:Group C GLS4 Subjects will receive GLS4+RTV on Day 1,followed by TDF on Day11-21 and co-administration with GLS4+RTV on Day 21. Part A:Group B ETV Subjects will receive ETV on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with ETV on Day 21. Part B:Group D TDF Subjects will receive TDF on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with TDF on Day 21. Part A:Group A ETV Subjects will receive GLS4+RTV on Day 1,followed by ETV on Day11-21 and co-administration with GLS4+RTV on Day 21. Part A:Group B GLS4 Subjects will receive ETV on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with ETV on Day 21. Part B:Group C TDF Subjects will receive GLS4+RTV on Day 1,followed by TDF on Day11-21 and co-administration with GLS4+RTV on Day 21. Part B:Group D GLS4 Subjects will receive TDF on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with TDF on Day 21. Part A:Group A RTV Subjects will receive GLS4+RTV on Day 1,followed by ETV on Day11-21 and co-administration with GLS4+RTV on Day 21. Part A:Group B RTV Subjects will receive ETV on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with ETV on Day 21. Part B:Group C RTV Subjects will receive GLS4+RTV on Day 1,followed by TDF on Day11-21 and co-administration with GLS4+RTV on Day 21. Part B:Group D RTV Subjects will receive TDF on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with TDF on Day 21.
- Primary Outcome Measures
Name Time Method T1/2 Day 1-2 and Day 21-23 Terminal half-life of study drugs
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
Cmax Day 1-2 and Day 21-23 Maximum plasma concentration of study drugs
Adverse events Baseline to day 23 To assess the safety and tolerability after dosing
- Secondary Outcome Measures
Name Time Method Cmin Day 1-2 and Day 21-23 Minimum plasma concentration of study drugs
Vz/F Day 1-2 and Day 21-23 Apparent volume of distribution of study drugs
CL/F Day 1-2 and Day 21-23 Apparent clearance of study drugs
Trial Locations
- Locations (1)
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China