Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT03662568
Status:
COMPLETED
Last Update Posted:
2019-10-09
First Post:
2018-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2018-09-05', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Day 1-2 and Day 21-23', 'description': 'Maximum plasma concentration of study drugs'}, {'measure': 'AUC', 'timeFrame': 'Day 1-2 and Day 21-23', 'description': 'Area under the plasma concentration-time curve of study drugs'}, {'measure': 'Tmax', 'timeFrame': 'Day 1-2 and Day 21-23', 'description': 'Time to maximum concentration of study drugs'}, {'measure': 'T1/2', 'timeFrame': 'Day 1-2 and Day 21-23', 'description': 'Terminal half-life of study drugs'}, {'measure': 'Adverse events', 'timeFrame': 'Baseline to day 23', 'description': 'To assess the safety and tolerability after dosing'}], 'secondaryOutcomes': [{'measure': 'CL/F', 'timeFrame': 'Day 1-2 and Day 21-23', 'description': 'Apparent clearance of study drugs'}, {'measure': 'Vz/F', 'timeFrame': 'Day 1-2 and Day 21-23', 'description': 'Apparent volume of distribution of study drugs'}, {'measure': 'Cmin', 'timeFrame': 'Day 1-2 and Day 21-23', 'description': 'Minimum plasma concentration of study drugs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'This is a 2-part study with each part is an open-label, crossover study in healthy adult subjects.\n\nTotal 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions\n* Be able to complete the study according to the trail protocol\n* Subjects (including partners) have no pregnancy plan within 1 year after the last dose of study drug and voluntarily take effective contraceptive measures\n* Male subjects and must be 18 to 45 years of age inclusive\n* Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg / m2, inclusive\n* Physical examination and vital signs without clinically significant abnormalities.\n\nExclusion Criteria:\n\n* Use of \\>5 cigarettes per day during the past 3 months\n* Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies)\n* 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)\n* Donation or loss of blood over 450 mL within 3 months prior to screening\n* 12-lead ECG with clinically significant\n* Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis\n* Subjects deemed unsuitable by the investigator for any other reason.'}, 'identificationModule': {'nctId': 'NCT03662568', 'briefTitle': 'A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sunshine Lake Pharma Co., Ltd.'}, 'officialTitle': 'A Open-label, Single Center Drug Interaction Study of Morphothiadine Mesilate/Ritonavir , Entecavir and Tenofovir Disoproxil Fumarate in Healthy Subjects', 'orgStudyIdInfo': {'id': 'PCD-DGLS4-18-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A:Group A', 'description': 'Subjects will receive GLS4+RTV on Day 1,followed by ETV on Day11-21 and co-administration with GLS4+RTV on Day 21.', 'interventionNames': ['Drug: GLS4', 'Drug: RTV', 'Drug: ETV']}, {'type': 'EXPERIMENTAL', 'label': 'Part A:Group B', 'description': 'Subjects will receive ETV on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with ETV on Day 21.', 'interventionNames': ['Drug: GLS4', 'Drug: RTV', 'Drug: ETV']}, {'type': 'EXPERIMENTAL', 'label': 'Part B:Group C', 'description': 'Subjects will receive GLS4+RTV on Day 1,followed by TDF on Day11-21 and co-administration with GLS4+RTV on Day 21.', 'interventionNames': ['Drug: GLS4', 'Drug: RTV', 'Drug: TDF']}, {'type': 'EXPERIMENTAL', 'label': 'Part B:Group D', 'description': 'Subjects will receive TDF on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with TDF on Day 21.', 'interventionNames': ['Drug: GLS4', 'Drug: RTV', 'Drug: TDF']}], 'interventions': [{'name': 'GLS4', 'type': 'DRUG', 'otherNames': ['Morphothiadine Mesilate Capsules'], 'description': 'Administered GLS4 120 mg orally three times daily in fed state', 'armGroupLabels': ['Part A:Group A', 'Part A:Group B', 'Part B:Group C', 'Part B:Group D']}, {'name': 'RTV', 'type': 'DRUG', 'otherNames': ['Ritonavir tablet'], 'description': 'Administered RTV 100 mg orally three times daily in fed state', 'armGroupLabels': ['Part A:Group A', 'Part A:Group B', 'Part B:Group C', 'Part B:Group D']}, {'name': 'ETV', 'type': 'DRUG', 'otherNames': ['Entecavir table'], 'description': 'Administered orally ETV 0.5 mg once daily in fasted state', 'armGroupLabels': ['Part A:Group A', 'Part A:Group B']}, {'name': 'TDF', 'type': 'DRUG', 'otherNames': ['Tenofovir Disoproxil Fumarate table'], 'description': 'Administered TDF 300 mg orally once daily in fasted state', 'armGroupLabels': ['Part B:Group C', 'Part B:Group D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'overallOfficials': [{'name': 'Yanhua Ding, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Hospital of Jilin University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunshine Lake Pharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}