Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 5:25 AM
Study NCT ID:
NCT04006860
Status:
UNKNOWN
Last Update Posted:
2019-07-05
First Post:
2019-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Food-Effect Study of SHC014748M in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2019-07-01', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC(0-t)', 'timeFrame': '72 hours', 'description': 'Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to last measurable concentration.'}, {'measure': 'AUC(0-∞)', 'timeFrame': '72 hours', 'description': 'Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to infinity'}, {'measure': 'Cmax', 'timeFrame': '72 hours', 'description': 'Pharmacokinetic of SHC014748M Capsules by assessment of maximum plasma concentration'}], 'secondaryOutcomes': [{'measure': 'tmax', 'timeFrame': '72 hours', 'description': 'Pharmacokinetic of SHC014748M Capsules by assessment of time to Cmax'}, {'measure': 'AUC[%Extrap obs]', 'timeFrame': '72 hours', 'description': 'Pharmacokinetic of SHC014748M Capsules by assessment of AUC\\[%Extrap obs\\],the rate of AUC(t-∞) to AUC'}, {'measure': 't l/2', 'timeFrame': '72 hours', 'description': 'Pharmacokinetic of SHC014748M Capsules by assessment of Terminal half life'}, {'measure': 'λz', 'timeFrame': '72 hours', 'description': 'Pharmacokinetic of SHC014748M Capsules by assessment of terminal rate constant'}, {'measure': 'CL/F', 'timeFrame': '72 hours', 'description': 'Pharmacokinetic of SHC014748M Capsules by assessment of apparent plasma clearance'}, {'measure': 'Vz/F', 'timeFrame': '72 hours', 'description': 'Pharmacokinetic of SHC014748M Capsules by assessment of apparent volume of distribution'}, {'measure': 'MRT', 'timeFrame': '72 hours', 'description': 'Pharmacokinetic of SHC014748M Capsules by assessment of Mean Residence Time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of SHC014748M Capsules following single dose administration with and without a meal.', 'detailedDescription': 'This study will be an open-label, randomized, two-period, crossover PK food effect study of SHC014748M Capsules administered orally at 200 mg.\n\nFor each of 2 study periods, subjects will be admitted to the clinical research unit on the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for each of the 2 study periods, subjects will receive a single oral dose of 200 mg SHC014748M Capsules in either the fasted or fed state. Subjects will remain at the clinical research unit for at least 72 hours after administration of study drug for collection of serial blood samples for pharmacokinetic (PK) analysis and safety monitoring.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Healthy male subject,18-45 years of age.\n\n 2\\. BMI between 19 and 26; Weight between 50 and 80 kg.\n\n 3\\. Healthy medical examination ,various laboratory inspection indicators normal, or the abnormal signs have no clinical significance.\n\n 4\\. Subjects (including their partners) who are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose.\n\n 5\\. Sign the informed consent form before the study and fully understand the study content, process and possible adverse reactions.\n\nExclusion Criteria:\n\n* 1\\. Nervous system, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, musculoskeletal system, etc. are abnormal and have clinical significance as determined by investigator.\n\n 2\\. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity.\n\n 3\\. Addicted to smoking and drinking in 3 months before the trial.\n\n 4\\. Hemorrhage over 200mL , receive blood transfusions or use blood products in 3 months before the trial.\n\n 5\\. Other conditions not suitable for trial, by judgement of investigator.'}, 'identificationModule': {'nctId': 'NCT04006860', 'briefTitle': 'A Food-Effect Study of SHC014748M in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nanjing Sanhome Pharmaceutical, Co., Ltd.'}, 'officialTitle': 'A Single-center, Open-label, Randomized, Two-period Crossover Food-effect Study of SHC014748M in Healthy Subjects', 'orgStudyIdInfo': {'id': 'SHC014-I-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHC014748M: Fast + Fed', 'description': 'Participants will receive a single oral dose of SHC014748M capsules in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of SHC014748M capsules in fed condition on Day 8 of treatment period 2.', 'interventionNames': ['Drug: SHC014748M Capsules']}, {'type': 'EXPERIMENTAL', 'label': 'SHC014748M: Fed + Fast', 'description': 'Participants will receive a single oral dose of SHC014748M capsules in fed condition on Day 1 of treatment period 1 followed by a single oral dose of SHC014748M capsules in fasted condition on Day 8 of treatment period 2.', 'interventionNames': ['Drug: SHC014748M Capsules']}], 'interventions': [{'name': 'SHC014748M Capsules', 'type': 'DRUG', 'description': 'SHC014748M Capsules: 200mg', 'armGroupLabels': ['SHC014748M: Fast + Fed', 'SHC014748M: Fed + Fast']}]}, 'contactsLocationsModule': {'locations': [{'zip': '233070', 'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'contacts': [{'name': 'Huan Zhou, associate professor', 'role': 'CONTACT', 'email': 'zhouhuan@bbmc.edu.cn', 'phone': '13665527160'}, {'name': 'Huaiquan Gao, associate', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Huan Zhou, associate', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Bengbu Medical College', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Sanhome Pharmaceutical, Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}