Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 6:57 AM
Study NCT ID:
NCT01291732
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2011-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Rising Dose Study of BI 135585 XX in Health Asian Male Volunteers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-31', 'studyFirstSubmitDate': '2011-02-07', 'studyFirstSubmitQcDate': '2011-02-07', 'lastUpdatePostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate(RR))', 'timeFrame': 'up to 21 days'}, {'measure': 'Changes in 12-lead ECG (electrocardiogram)', 'timeFrame': 'up to 21 days'}, {'measure': 'Changes in Clinical laboratory tests (haematology, clinical chemistry and urinalysis)', 'timeFrame': 'up to 21 days'}, {'measure': 'Occurrence of Adverse events', 'timeFrame': 'up to 21 days'}], 'secondaryOutcomes': [{'measure': 'Cmax (maximum measured concentration of the analyte in plasma)', 'timeFrame': '10 days'}, {'measure': 'Tmax (maximum measured concentration of the analyte in plasma)', 'timeFrame': '10 days'}, {'measure': 'AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)', 'timeFrame': '10 days'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Healthy male volunteers,\n2. Chinese or Japanese ethnicity\n\nExclusion criteria:\n\n1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance according to the investigators medical judgement\n2. Any evidence of a clinically relevant concomitant disease\n3. Intake of drugs with long half life (\\>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration'}, 'identificationModule': {'nctId': 'NCT01291732', 'briefTitle': 'Single Rising Dose Study of BI 135585 XX in Health Asian Male Volunteers.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (12.5 mg, 50 mg, 200 mg) of BI 135585 XX (Tablet) in Chinese and Japanese Healthy Male Volunteers (Randomised, Double-blind,Placebo-controlled Within Dose Groups)', 'orgStudyIdInfo': {'id': '1283.5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 135585 XX', 'description': 'single dose of BI 135585', 'interventionNames': ['Drug: BI 135585 XX']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'matching placebo', 'description': 'single dose of matching placebo', 'interventionNames': ['Drug: Matching placebo']}], 'interventions': [{'name': 'Matching placebo', 'type': 'DRUG', 'description': 'single dose of matching placebo', 'armGroupLabels': ['matching placebo']}, {'name': 'BI 135585 XX', 'type': 'DRUG', 'description': 'single dose of low, medium or high dose of BI 135585 XX', 'armGroupLabels': ['BI 135585 XX']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': '1283.5.82001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Boehringer Ingelheim, Study Chair', 'oldOrganization': 'Boehringer Ingelheim'}}}}