Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-09 @ 1:22 AM
Study NCT ID:
NCT01611805
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2012-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Japanese Phase I of GSK1605786
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2010-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2012-04-12', 'studyFirstSubmitQcDate': '2012-05-31', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration', 'timeFrame': 'up to 72h post dose'}], 'secondaryOutcomes': [{'measure': 'Adverse envents', 'timeFrame': 'up to 72h post dose'}, {'measure': 'Vital signe', 'timeFrame': 'up to 72h post dose'}, {'measure': 'Clinical laboratory', 'timeFrame': 'up to 72h post dose'}, {'measure': '12 lead ECG', 'timeFrame': 'up to 72h post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://gsk-clinicalstudyregister.com/study/114472?search=study&search_terms=114472#rs', 'label': 'Results for study 114472 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'This is an double-blind, single dose, four-period, crossover study in Japanese healthy male volunteers to assess the pharmacokinetics and safety/tolerability of single doses of GSK1605786A. Approximately 24 subjects will receive three treatments of 250, 500, and 1000mg GSK1605786 under fasted conditions or 500mg after food intake plus placebo in a dose ascending crossover design. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The pharmacokinetics and dose proportionality of GSK1605786 after single oral doses of GSK1605786 at the dose levels of 250mg, 500mg and 1000 mg under fasted conditions will be assessed. In addition, a comparison will be made between the pharmacokinetics of GSK1605786 under fed and fasted conditions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Japanese as\n* Japanese defined as being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity -Male between 20 and 55 years of age inclusive, at the time of signing the informed consent.\n* Body weight =\\>50kg and BMI within the range 18.5 - 25 kg/m2 (inclusive).\n\nExclusion Criteria:\n\n\\- Known coeliac disease or positive serologic testing for anti-tTG antibodies (required to screen for undiagnosed celiac disease)'}, 'identificationModule': {'nctId': 'NCT01611805', 'briefTitle': 'Japanese Phase I of GSK1605786', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Placebo-Controlled, Four-Period Crossover, Single Ascending Oral Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of the CCR9 Receptor Antagonist GSK1605786 in Japanese Healthy Male Subject', 'orgStudyIdInfo': {'id': '114472'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSK1605786 250mg', 'description': 'Opaque Swedish orange body and cap.', 'interventionNames': ['Drug: GSK1605786']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Opaque Swedish orange body and cap.', 'interventionNames': ['Drug: GSK1605786 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'GSK1605786 500mg', 'description': 'Opaque Swedish orange body and cap.', 'interventionNames': ['Drug: GSK1605786']}, {'type': 'EXPERIMENTAL', 'label': 'GSK1605786 1000mg', 'description': 'Opaque Swedish orange body and cap.', 'interventionNames': ['Drug: GSK1605786']}, {'type': 'EXPERIMENTAL', 'label': 'GSK1605786 500mg in fed', 'description': 'Opaque Swedish orange body and cap.', 'interventionNames': ['Drug: GSK1605786']}], 'interventions': [{'name': 'GSK1605786', 'type': 'DRUG', 'description': 'Opaque Swedish orange body and cap.', 'armGroupLabels': ['GSK1605786 1000mg', 'GSK1605786 250mg', 'GSK1605786 500mg', 'GSK1605786 500mg in fed']}, {'name': 'GSK1605786 Placebo', 'type': 'DRUG', 'description': 'Opaque Swedish orange body and cap.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}