Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT02075268
Status:
UNKNOWN
Last Update Posted:
2014-03-04
First Post:
2014-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Characterize Pharmacokinetic-pharmacodynamic (PKPD) of Prasugrel 10 mg or 30 mg in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068799', 'term': 'Prasugrel Hydrochloride'}, {'id': 'D004341', 'term': 'Drug Evaluation'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000076722', 'term': 'Drug Development'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-28', 'studyFirstSubmitDate': '2014-02-27', 'studyFirstSubmitQcDate': '2014-02-27', 'lastUpdatePostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma R-138727 and R-95913 concentrations', 'timeFrame': 'predose, 10 min, 15 min, 25 min, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 4 h, 6 h, 8 h, 12 h and 24 h after dosing'}], 'secondaryOutcomes': [{'measure': 'Maximal platelet aggregation', 'timeFrame': 'predose, 15 min, 0.5 h, 1 h, 2 h, 4 h, 8 h, 24 h, 48 h and 72 h after dosing', 'description': 'Maximal platelet aggregation will be measured by light transmission test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Korean', 'Healthy', 'Male'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '25697420', 'type': 'DERIVED', 'citation': 'Jeon HS, Kim MJ, Choi HY, Kim YH, Kim EH, Kim AR, Park HJ, Bae KS, Lim HS. Pharmacokinetics and pharmacodynamics of ticagrelor and prasugrel in healthy male Korean volunteers. Clin Ther. 2015 Mar 1;37(3):563-73. doi: 10.1016/j.clinthera.2015.01.010. Epub 2015 Feb 16.'}]}, 'descriptionModule': {'briefSummary': 'An open label, parallel study to characterize the pharmacokinetics and pharmacodynamics of Prasugrel 30 mg or 60 mg in healthy male adult subjects', 'detailedDescription': '1. Screening\n2. Enrollment and treatment randomization\n3. Confinement to Research Unit from day - 1 to day 2\n4. Outpatient visit : 2 times ( 48 and 73 hours after dosing)\n5. Drug administration : Overnight Fasting\n6. Blood sampling for PK, PD and genotyping\n\n 1. PK: up to 24 hours after dosing\n 2. PD: up to 72 hours after dosing'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male aged 19 to 45 years\n* weigh over 60 kg\n* body mass index 18 to 30 kg/m2\n\nExclusion Criteria:\n\n* any history or state of clinically significant disease\n* any gastrointestinal disease may interfere absorption of drug\n* any history of hypersensitivity to prasugrel or other drug\n* any history of taking herbal medication within 30 days before dosing or taking prescription medication within 14 days before dosing or taking over the counter drug within 7 days before dosing\n* taking investigational drug within 60 days before dosing\n* transfused within 30 days or donated blood within 60 days before dosing\n* Positive serology test ( Hepatitis B surface antigen (HBs Ag), HIV, HCV)\n* Clinically significant finding in laboratory result or electrocardiogram result'}, 'identificationModule': {'nctId': 'NCT02075268', 'acronym': 'PRAS-AM', 'briefTitle': 'Clinical Trial to Characterize Pharmacokinetic-pharmacodynamic (PKPD) of Prasugrel 10 mg or 30 mg in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'An Open Label, Single Dose Study to Characterize the Pharmacokinetics and Pharmacodynamics of Prasugrel in Healthy Male Adult Subjects', 'orgStudyIdInfo': {'id': 'PRAS-AM'}, 'secondaryIdInfos': [{'id': '2014-0064', 'type': 'OTHER', 'domain': 'Institutional review board of Asan Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '10 mg, 30 mg', 'description': 'To compare PKPD of prasugrel 10 or 30 mg, 4 subjects will be given 10 mg of prasugrel (one tablet of 10 mg of Effient) on day 1 as a single oral dose and another 4 subjects will be given 30 mg of prasugrel (3 tablets of 10 mg of Effient) on day 1 as a single oral dose.', 'interventionNames': ['Drug: prasugrel']}], 'interventions': [{'name': 'prasugrel', 'type': 'DRUG', 'otherNames': ['Effient 10 mg tablet will be used as study drug.'], 'description': 'prausugrel 10 or 30 mg will be administrated as single dose under overnight fast.', 'armGroupLabels': ['10 mg, 30 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'MI Jo Kim, MD', 'role': 'CONTACT', 'email': 'mjk0326@gmail.com', 'phone': '82-2-3010-4622'}, {'name': 'Hyeong-Suk Lim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hyeong-Seok Lim', 'investigatorAffiliation': 'Asan Medical Center'}}}}