Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-02-20 @ 10:08 PM
Study NCT ID:
NCT01766167
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2013-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Pharmacology Study of MP-424
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2013-01-06', 'studyFirstSubmitQcDate': '2013-01-09', 'lastUpdatePostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MP-424 area under the plasma concentration-time curve (AUC) from 0 to infinity in Korean healthy volunteers', 'timeFrame': 'up to 1 week'}, {'measure': 'Number of participants with adverse events as a measure of safety and tolerability in Korean healthy volunteers', 'timeFrame': 'up to 2 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Genotype 2'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'To conduct the following evaluations in Korean healthy male adult volunteers receiving a single and multiple doses of MP-424 tablets:\n\n* Pharmacokinetics of MP-424 after a single and multiple doses.\n* Safety and tolerability of single and multiple doses of MP-424.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Korean healthy male volunteers aged 20 to 55 years\n\nExclusion Criteria:\n\n* Subjects with a BMI of \\<18.5 or \\>25.0, or body weight of \\<50kg at prior examination\n* Subjects who have had surgery that is known to affect gastrointestinal absorption of drugs (except for appendectomy and hernia surgery)\n* Subjects who have had any evidence of cardiac disease at prior examination or who have a previous history of cardiac disease\n* Subjects who are positive for HBs antigen, serologic tests for syphilis, HCV antibody, or HIV antibody at prior examination\n* Subjects who have experienced symptoms of alcohol abuse or excessive alcohol ingestion\n* Subjects who test positive on urinalysis for drug use (amphetamine, benzodiazepine, barbiturates, cannabinoid, cocaine, opiates, and methadone) at prior examination\n* Subjects who do not agree to use a physical contraceptive method during the study period\n* Subjects who do not agree to use contraceptive methods for 90 days after final administration of the study drug\n* Subjects who have consumed grapefruit, Seville orange, star fruit, cranberry, or any processed food containing these fruits within 7 days before the commencement of study drug administration\n* Subjects who have consumed health foods containing St John's Wort within 2 weeks before study drug administration"}, 'identificationModule': {'nctId': 'NCT01766167', 'briefTitle': 'Clinical Pharmacology Study of MP-424', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'Clinical Pharmacology Study of MP-424 in Healthy Male Adult Volunteers (Single- and Multiple-Dose Study)', 'orgStudyIdInfo': {'id': 'MP-424-K01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MP-424', 'interventionNames': ['Drug: MP-424']}], 'interventions': [{'name': 'MP-424', 'type': 'DRUG', 'description': 'Low', 'armGroupLabels': ['MP-424']}, {'name': 'MP-424', 'type': 'DRUG', 'description': 'Middle', 'armGroupLabels': ['MP-424']}, {'name': 'MP-424', 'type': 'DRUG', 'description': 'High', 'armGroupLabels': ['MP-424']}, {'name': 'MP-424', 'type': 'DRUG', 'description': 'Multiple', 'armGroupLabels': ['MP-424']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kazuoki Kondo, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}