Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-26 @ 5:45 PM
Study NCT ID:
NCT02409394
Status:
COMPLETED
Last Update Posted:
2015-04-06
First Post:
2015-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study 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': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-03', 'studyFirstSubmitDate': '2015-04-01', 'studyFirstSubmitQcDate': '2015-04-03', 'lastUpdatePostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The maximum plasma concentration (Cmax) of hetrombopag', 'timeFrame': '0h-120h', 'description': "Cmax (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state"}, {'measure': 'The area under the plasma concentration-time curve (AUC) of hetrombopag', 'timeFrame': '0h-120h', 'description': "AUC (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state"}, {'measure': 'The accumulative excretion rate of hetrombopag and its metabolites in urine and feces', 'timeFrame': '0h-120h'}], 'secondaryOutcomes': [{'measure': 'The change of platelet count', 'timeFrame': 'On day 2, 4, 6, 8,12, 14 and 16'}, {'measure': 'The number of volunteers with adverse events as a measure of safety and tolerability', 'timeFrame': 'up to Day 16'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Subjects'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '33109386', 'type': 'DERIVED', 'citation': 'Wang Z, Chen X, Li A, Chen L, Wang Y, Zheng L. Effect of Food on the Pharmacokinetic and Pharmacodynamic Profiles of Hetrombopag in Healthy Volunteers. Clin Ther. 2020 Dec;42(12):2280-2288. doi: 10.1016/j.clinthera.2020.10.002. Epub 2020 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy.\n* Weight≥50 kg，19≤BMI≤28 kg/m2.\n* Platelet count is within normal range\n\nExclusion Criteria:\n\n* History of clinically significant illness.\n* History of alcohol or drug abuse.'}, 'identificationModule': {'nctId': 'NCT02409394', 'briefTitle': 'Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects', 'orgStudyIdInfo': {'id': 'TPOP1c'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hetrombopag 7.5mg fasted to fed', 'description': 'Hetrombopag tablet, fasting conditions on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet with high fat, high calorie breakfast on day 11.', 'interventionNames': ['Drug: Hetrombopag Olamine']}, {'type': 'EXPERIMENTAL', 'label': 'hetrombopag 7.5mg fed to fasted', 'description': 'Hetrombopag tablet with high fat, high calorie breakfast on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet, under fasting condition on day 11.', 'interventionNames': ['Drug: Hetrombopag Olamine']}], 'interventions': [{'name': 'Hetrombopag Olamine', 'type': 'DRUG', 'armGroupLabels': ['hetrombopag 7.5mg fasted to fed', 'hetrombopag 7.5mg fed to fasted']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}