Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-02 @ 6:43 AM
Study NCT ID:
NCT03159832
Status:
UNKNOWN
Last Update Posted:
2017-05-19
First Post:
2017-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000611095', 'term': 'henagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-17', 'studyFirstSubmitDate': '2017-05-17', 'studyFirstSubmitQcDate': '2017-05-17', 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The area under the plasma concentration-time curve (AUC) of SHR3824', 'timeFrame': '72 hours after dosing', 'description': "AUC (a measure of the body's exposure to SHR3824) will be compared between normal renal function patients and mild or moderate renal dysfunction patients"}, {'measure': 'The maximum plasma concentration (Cmax) of SHR3824', 'timeFrame': '72 hours after dosing', 'description': "Cmax (a measure of the body's exposure to SHR3824) will be compared between normal renal function patients and mild or moderate renal dysfunction patients"}], 'secondaryOutcomes': [{'measure': 'The number of volunteers with adverse events as a measure of safety and tolerability', 'timeFrame': '72 hours after dosing', 'description': 'The number of volunteers with adverse events as a measure of safety and tolerability'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Efficacy', 'PK/PD study', 'Renal Insufficiency', 'Type 2 Diabetes'], 'conditions': ['Renal Insufficiency,Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient.', 'detailedDescription': 'This trial was a parallel, open-label, single dose study. The subject was divided into one of three groups according to the degree of renal Insufficiency,including normal, mild and moderate. All subjects were given SHR3824 20mg, the blood and urine samples were collected before and after dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* with a body mass index(BMI) between 19 and 33 Kg/m2;\n* The estimated glomerular filtration rate (eGFR)of subjects in groups must meet the corresponding standards:mild renal insufficiency:60 to 89 ml/min/1.73m2;Moderate renal insufficiency: 30 to 59 ml/min/1.73m2.\n* Had signed the informed consent himself or herself voluntarily.\n\nExclusion Criteria:\n\n* Urinary tract infections, or vulvovaginal mycotic infections\n* Suspected or diagnosed as kidney cancer or other malignancies in patients\n* Autoimmune kidney disease, history of renal transplantation, dialysis patients being treated\n* History of or current clinically significant medical illness as determined by the Investigator\n* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose\n* Known allergy to SHR3824,SGLT2 inhibitor analogs, or any other structural analogs\n* Alcohol, tobacco, drug abusers;alcohol abuse is defined as a day for regular alcohol consumption more than the following standards: beer 570 ml, light beer 750 ml, red wine 200 ml, white wine 60 ml, which including about 20g alcohol;Tobacco is defined as five or more per day.\n* Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.\n* Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects."}, 'identificationModule': {'nctId': 'NCT03159832', 'briefTitle': 'Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient (Open-label, Parallel-Group, Single-Dose Study)', 'orgStudyIdInfo': {'id': 'SHR3824-110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Normal renal function', 'description': 'All subjects were given SHR3824 20mg only one time.', 'interventionNames': ['Drug: SHR3824']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mild renal dysfunction', 'description': 'All subjects were given SHR3824 20mg only one time.', 'interventionNames': ['Drug: SHR3824']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate renal dysfunction', 'description': 'All subjects were given SHR3824 20mg only one time.', 'interventionNames': ['Drug: SHR3824']}], 'interventions': [{'name': 'SHR3824', 'type': 'DRUG', 'description': 'All subjects were given SHR3824 20mg only one time.', 'armGroupLabels': ['Mild renal dysfunction', 'Moderate renal dysfunction', 'Normal renal function']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xiaolan yong', 'role': 'CONTACT'}], 'facility': "Chinese people's liberation army general hospital of Chengdu military area", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Haiyan Liu, Phd', 'role': 'CONTACT', 'phone': '+86-15705155025'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}