Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-02 @ 3:08 AM
Study NCT ID:
NCT02183259
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2014-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL in Healthy Adult Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002214', 'term': 'Capsules'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-04', 'studyFirstSubmitDate': '2014-07-04', 'studyFirstSubmitQcDate': '2014-07-04', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1998-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma drug concentration-time curve from time zero to infinity', 'timeFrame': 'up to 16 hours after drug administration'}, {'measure': 'maximum drug plasma concentration (Cmax)', 'timeFrame': 'up to 16 hours after drug administration'}, {'measure': 'time to achieve maximum drug plasma concentration (tmax)', 'timeFrame': 'up to 16 hours after drug administration'}, {'measure': 'elimination half-life (t1/2)', 'timeFrame': 'up to 16 hours after drug administration'}, {'measure': 'mean residence time (MRT)', 'timeFrame': 'up to 16 hours after drug administration'}, {'measure': 'total clearance (CL)', 'timeFrame': 'up to 16 hours after drug administration'}], 'secondaryOutcomes': [{'measure': 'number of adverse events', 'timeFrame': 'up to day 22'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150 CL.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male subjects\n* age: \\>= 20 and \\<= 35 years\n* weight: \\>= 50 to \\<= 80 kg and within +/- 20 % of standard weight\n* blood pressure: systolic 100 - 138 mmHg and diastolic of less than 84 mmHg\n* pulse rate: 45 to 80 beat/min\n* volunteer whose participation in the trial is judged valid by the investigator based on the results of preliminary check-up and pre-administration check-up\n\nExclusion Criteria:\n\n* history of diseases including cardiac, pulmonary, hepatic, renal or gastrointestinal disease\n* history of drug allergy\n* history of drug dependency, alcohol dependency, etc.\n* use of other trial drug within 6 months before study drug administration\n* use of any drugs within 7 days before study drug administration'}, 'identificationModule': {'nctId': 'NCT02183259', 'briefTitle': 'Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL in Healthy Adult Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Absolute Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL 1 mg Capsule Compared to 0.015 mg Solution i.v. as Single Administration in Healthy Male Subjects (Open-labelled, 2-way Cross-over Study)', 'orgStudyIdInfo': {'id': '1172.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESR 1150 CL capsule', 'interventionNames': ['Drug: ESR 1150 CL, Capsule, oral']}, {'type': 'EXPERIMENTAL', 'label': 'ESR 1150 CL ampoule', 'interventionNames': ['Drug: ESR 1150 CL, solution, intravenous']}], 'interventions': [{'name': 'ESR 1150 CL, Capsule, oral', 'type': 'DRUG', 'armGroupLabels': ['ESR 1150 CL capsule']}, {'name': 'ESR 1150 CL, solution, intravenous', 'type': 'DRUG', 'armGroupLabels': ['ESR 1150 CL ampoule']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}