Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT02268760
Status:
COMPLETED
Last Update Posted:
2014-10-20
First Post:
2014-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerance, and Pharmacokinetics of BILN 2061 ZW in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C479555', 'term': 'BILN 2061'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-17', 'studyFirstSubmitDate': '2014-10-17', 'studyFirstSubmitQcDate': '2014-10-17', 'lastUpdatePostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with clinically relevant changes in vital signs (systolic and diastolic blood pressure, pulse rate)', 'timeFrame': 'Pre-dose, up to 48 hours after drug administration'}, {'measure': 'Changes from baseline in laboratory tests', 'timeFrame': 'Pre-dose and 48 hours after drug administration'}, {'measure': 'Number of patients with clinically relevant changes in 12-lead ECG', 'timeFrame': 'Pre-dose, up to 48 hours after drug administration'}, {'measure': 'Changes from baseline in physical examination', 'timeFrame': 'Pre-dose and 48 hours after drug administration'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'Up to 48 hours after drug administration'}, {'measure': 'Global assessment of tolerability by the investigator on a 4-point scale', 'timeFrame': 'Up to 48 hours after drug administration'}, {'measure': 'Maximum concentration of the analyte in plasma after a single dose administration (Cmax)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Area under the concentration-time curve of the analyte in plasma from time 0 to infinity (AUC0-infinity)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Time to reach Cmax following a single dose administration (tmax)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Elimination half-life of the analyte in plasma (t1/2)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Total oral clearance of the analyte from plasma after oral administration, divided by F (bioavailability factor) (CL/F)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Total mean residence time of the analyte in plasma (MRT)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Apparent volume of distribution during the terminal elimination phase (Vz/F)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Amount of intact drug excreted in urine (Au)', 'timeFrame': 'up to 48 hours after drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW\n\n1. In rising single doses\n2. With and without a 64 g fat breakfast at one selected dose'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects as determined by results of screening\n* Signed written informed consent in accordance with good clinical practice (GCP) and local legislation\n* Age ≥ 18 and ≤ 50 years\n* Broca ≥ - 20 % and ≤ + 20 %\n\nExclusion Criteria:\n\n* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance\n* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection\n* History of orthostatic hypotension, fainting spells and blackouts\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\n* Chronic or relevant acute infections\n* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator\n* Intake of drugs with a long half-life (\\> 24 hours) within 1 month prior to administration\n* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial\n* Participation in another trial with an investigational drug within 1 month prior to administration or during the trial\n* Smoker (\\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on trial days\n* Alcohol abuse (\\> 60 g/day)\n* Drug abuse\n* Blood donation within 1 month prior to administration or during the trial\n* Excessive physical activities within 5 days prior to administration or during the trial\n* Any laboratory value outside the clinically accepted reference range and of clinical relevance\n* History of any familial bleeding disorder'}, 'identificationModule': {'nctId': 'NCT02268760', 'briefTitle': 'Safety, Tolerance, and Pharmacokinetics of BILN 2061 ZW in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 5 mg, 20 mg, 60 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg, 1000 mg, 1200 mg, 1500 mg, 2000 mg and 2400 mg BILN 2061 ZW (PEG 400: Ethanol Solution) in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect of the Dose of 200 mg (Two-Stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Part and Subsequent Open Intraindividual Comparison Part)', 'orgStudyIdInfo': {'id': '605.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BILN 2061 ZW single rising doses', 'interventionNames': ['Drug: BILN 2061 ZW single rising doses']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BILN 2061 ZW fixed dose fed', 'interventionNames': ['Drug: BILN 2061 ZW fixed dose', 'Other: Standardized breakfast']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BILN 2061 ZW fixed dose fasted', 'interventionNames': ['Drug: BILN 2061 ZW fixed dose']}], 'interventions': [{'name': 'BILN 2061 ZW single rising doses', 'type': 'DRUG', 'armGroupLabels': ['BILN 2061 ZW single rising doses']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}, {'name': 'BILN 2061 ZW fixed dose', 'type': 'DRUG', 'armGroupLabels': ['BILN 2061 ZW fixed dose fasted', 'BILN 2061 ZW fixed dose fed']}, {'name': 'Standardized breakfast', 'type': 'OTHER', 'armGroupLabels': ['BILN 2061 ZW fixed dose fed']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}