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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662568
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: GLS4 Drug: RTV Drug: ETV Drug: TDF Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Open-label, Single Center Drug Interaction Study of Morphothiadine Mesilate/Ritonavir , Entecavir and Tenofovir Disoproxil Fumarate in Healthy Subjects
Actual Study Start Date : June 26, 2018
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : June 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Ritonavir

Arm Intervention/treatment
Experimental: Part A:Group A
Subjects will receive GLS4+RTV on Day 1,followed by ETV on Day11-21 and co-administration with GLS4+RTV on Day 21.
Drug: GLS4
Administered GLS4 120 mg orally three times daily in fed state
Other Name: Morphothiadine Mesilate Capsules

Drug: RTV
Administered RTV 100 mg orally three times daily in fed state
Other Name: Ritonavir tablet

Drug: ETV
Administered orally ETV 0.5 mg once daily in fasted state
Other Name: Entecavir table

Experimental: Part A:Group B
Subjects will receive ETV on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with ETV on Day 21.
Drug: GLS4
Administered GLS4 120 mg orally three times daily in fed state
Other Name: Morphothiadine Mesilate Capsules

Drug: RTV
Administered RTV 100 mg orally three times daily in fed state
Other Name: Ritonavir tablet

Drug: ETV
Administered orally ETV 0.5 mg once daily in fasted state
Other Name: Entecavir table

Experimental: Part B:Group C
Subjects will receive GLS4+RTV on Day 1,followed by TDF on Day11-21 and co-administration with GLS4+RTV on Day 21.
Drug: GLS4
Administered GLS4 120 mg orally three times daily in fed state
Other Name: Morphothiadine Mesilate Capsules

Drug: RTV
Administered RTV 100 mg orally three times daily in fed state
Other Name: Ritonavir tablet

Drug: TDF
Administered TDF 300 mg orally once daily in fasted state
Other Name: Tenofovir Disoproxil Fumarate table

Experimental: Part B:Group D
Subjects will receive TDF on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with TDF on Day 21.
Drug: GLS4
Administered GLS4 120 mg orally three times daily in fed state
Other Name: Morphothiadine Mesilate Capsules

Drug: RTV
Administered RTV 100 mg orally three times daily in fed state
Other Name: Ritonavir tablet

Drug: TDF
Administered TDF 300 mg orally once daily in fasted state
Other Name: Tenofovir Disoproxil Fumarate table




Primary Outcome Measures :
  1. Cmax [ Time Frame: Day 1-2 and Day 21-23 ]
    Maximum plasma concentration of study drugs

  2. AUC [ Time Frame: Day 1-2 and Day 21-23 ]
    Area under the plasma concentration-time curve of study drugs

  3. Tmax [ Time Frame: Day 1-2 and Day 21-23 ]
    Time to maximum concentration of study drugs

  4. T1/2 [ Time Frame: Day 1-2 and Day 21-23 ]
    Terminal half-life of study drugs

  5. Adverse events [ Time Frame: Baseline to day 23 ]
    To assess the safety and tolerability after dosing


Secondary Outcome Measures :
  1. CL/F [ Time Frame: Day 1-2 and Day 21-23 ]
    Apparent clearance of study drugs

  2. Vz/F [ Time Frame: Day 1-2 and Day 21-23 ]
    Apparent volume of distribution of study drugs

  3. Cmin [ Time Frame: Day 1-2 and Day 21-23 ]
    Minimum plasma concentration of study drugs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662568


Locations
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China, Jilin
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Sponsors and Collaborators
Sunshine Lake Pharma Co., Ltd.
Investigators
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Principal Investigator: Yanhua Ding, Doctor First Hospital of Jilin University
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Responsible Party: Sunshine Lake Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT03662568    
Other Study ID Numbers: PCD-DGLS4-18-001
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic
Ritonavir
Tenofovir
Entecavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors