Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-02-18 @ 2:48 AM
Study NCT ID:
NCT03973632
Status:
UNKNOWN
Last Update Posted:
2019-06-04
First Post:
2019-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of SH-1028 Tablets in Healthy Subjects Under Fasting and Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000728623', 'term': 'SH-1028'}]}}, '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': '2019-05', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-02', 'studyFirstSubmitDate': '2019-05-31', 'studyFirstSubmitQcDate': '2019-06-02', 'lastUpdatePostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to infinity (AUC)', 'timeFrame': 'Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2(Each cycle is 4 days with a 3-days interval).'}, {'measure': 'Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to last measurable concentration [AUC(0-t)]', 'timeFrame': 'Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Every cycle is 4 days with a 3-days interval).'}, {'measure': 'Pharmacokinetic of SH-1028 Tablets by assessment of time to Cmax (tmax)', 'timeFrame': 'Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Every cycle is 4 days with a 3-days interval).'}], 'secondaryOutcomes': [{'measure': 'Adverse event（AE）rate and serious adverse event（SAE）rate', 'timeFrame': 'From signing of informed consent to ending of the trial, about 25 days.'}, {'measure': 'Pharmacokinetic of SH-1028 Tablets by assessment of maximum plasma concentration (Cmax)', 'timeFrame': 'Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).'}, {'measure': 'Pharmacokinetic of SH-1028 Tablets by assessment of terminal rate constant (λz) [', 'timeFrame': 'Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).'}, {'measure': 'Pharmacokinetic of SH-1028 Tablets by assessment of Terminal half life (t1/2）', 'timeFrame': 'Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).'}, {'measure': 'Pharmacokinetic of SH-1028 Tablets by assessment of apparent plasma clearance (CL/F)', 'timeFrame': 'Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).'}, {'measure': 'Pharmacokinetic of SH-1028 Tablets by assessment of apparent volume of distribution (Vz/F)', 'timeFrame': 'Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).'}, {'measure': 'Pharmacokinetic of SH-1028 Tablets by assessment of Mean Residence Time（MRT）', 'timeFrame': 'Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).'}, {'measure': 'Pharmacokinetic of SH-1028 Tablets by assessment of AUC[%Extrap obs],the rate of AUC(t-∞) to AUC', 'timeFrame': 'Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'To evaluate the food-effect of SH-1028 Tablets by pharmacokinetics in healthy subjects under fasting and fed conditions.', 'detailedDescription': 'By analyzing safety and pharmacokinetics of SH-1028 Tablets in healthy subjects, pharmacokinetic characteristic will be evaluated mainly under fasting and fed conditions.Safety including AE/SAE is also a significant secondary objective.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy Subject with acceptable laboratory results.\n2. BMI between 19 and 26; Weight between 50 and 80 kg\n3. Not allowed to smoke or drink during the trial.\n4. Subject should be willing to contracept during the study and until 6 months after completion of study.\n\nExclusion Criteria:\n\n1. Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.\n2. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity\n3. Addicted to smoking and drinking.\n4. Hemorrhage over 200mL in 3 months before the trial.\n5. Other conditions not suitable for trial, by judgement of investigator.'}, 'identificationModule': {'nctId': 'NCT03973632', 'briefTitle': 'Pharmacokinetic Study of SH-1028 Tablets in Healthy Subjects Under Fasting and Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nanjing Sanhome Pharmaceutical, Co., Ltd.'}, 'officialTitle': 'A Phase I, Open-label, Single-center, Crossover Design of Food-effect Study of SH-1028 Tablets in Healthy Subjects', 'orgStudyIdInfo': {'id': 'SHC013-I-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Fasting at last 10h before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 1，Feeding with high-fat diet within 30 minutes before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 2. Each cycle is 4 days with a 3-days interval.', 'interventionNames': ['Drug: SH-1028 Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Feeding with high-fat diet within 30 minutes before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 1，Fasting at last 10h before taking 200mg（two pills） of SH-1028 tablets on Day 1 of cycle 2. Each cycle is 4 days with a 3-days interval.', 'interventionNames': ['Drug: SH-1028 Tablets']}], 'interventions': [{'name': 'SH-1028 Tablets', 'type': 'DRUG', 'description': '200mg of SH-1028 Tablets, orally once every cycle.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhou Huan, associate professor', 'role': 'CONTACT', 'email': 'zhouhuan@bbmc.edu.cn', 'phone': '13665527160'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Sanhome Pharmaceutical, Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}