Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-29 @ 4:32 AM
Study NCT ID:
NCT03090568
Status:
COMPLETED
Last Update Posted:
2017-03-27
First Post:
2017-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of BIA 5-453
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C509002', 'term': 'etamicastat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2008-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-20', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-03-20', 'lastUpdatePostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - the maximum plasma concentration', 'timeFrame': 'pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose'}, {'measure': 'Tmax - the time of occurrence of Cmax', 'timeFrame': 'pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose'}, {'measure': 'AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time', 'timeFrame': 'pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose'}, {'measure': 'AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity', 'timeFrame': 'pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Congestive Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the bioavailability and tolerability of BIA 5-453 under fasted and fed conditions.', 'detailedDescription': 'This was a Single-centre, two-way crossover, randomised, open-label study in 12 healthy male volunteers. Subjects received a single oral 200 mg dose of BIA 5-453 following a standard meal in one period, and following at least 10 hours of fasting in another period. Treatment periods were separated by a washout interval of 2 weeks or more.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* aged between 18 and 45 years, inclusive.\n* had a body mass index (BMI) between 19 and 30 kg/m2, inclusive.\n* were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.\n* had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening\n* had clinical laboratory test results clinically acceptable at screening and admission to the first treatment period.\n* had negative screen for alcohol and drugs of abuse at screening and admission to the first treatment period.\n* were non-smokers or smoked ≤ 10 cigarettes or equivalent per day.\n* was able and willing to give written informed consent.\n\nExclusion Criteria:\n\n* had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.\n* had a clinically relevant surgical history.\n* had a clinically relevant family history.\n* had a history of relevant atopy or drug hypersensitivity.\n* had a history of alcoholism or drug abuse.\n* consumed more than 14 units of alcohol a week.\n* had a significant infection or known inflammatory process at screening or admission to the first treatment period.\n* had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the first treatment period.\n* used medicines within 2 weeks of admission to first period that affected the safety or other study assessments, in the investigator's opinion.\n* used any investigational drug or participated in any clinical trial within 3 months prior to screening.\n* participated in more than 2 clinical trials within the 12 months prior to screening.\n* donated or received any blood or blood products within the 3 months prior to screening.\n* was a vegetarian, vegan or with medical dietary restrictions.\n* could not communicate reliably with the investigator.\n* was unlikely to co-operate with the requirements of the study.\n* was unwilling or unable to give written informed consent."}, 'identificationModule': {'nctId': 'NCT03090568', 'briefTitle': 'Bioavailability Study of BIA 5-453', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bial - Portela C S.A.'}, 'officialTitle': 'Comparative Bioavailability Study of BIA 5-453 Under Fasted and Fed Conditions', 'orgStudyIdInfo': {'id': 'BIA-5453-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIA 5-453 Fasting', 'description': 'BIA 5-453 200 mg in fasting conditions', 'interventionNames': ['Drug: BIA 5-453']}, {'type': 'EXPERIMENTAL', 'label': 'BIA 5-453 Fed', 'description': 'BIA 5-453 200 mg in fed conditions', 'interventionNames': ['Drug: BIA 5-453']}], 'interventions': [{'name': 'BIA 5-453', 'type': 'DRUG', 'otherNames': ['Etamicastat'], 'description': 'BIA 5-453 capsules 50 mg. Route of administration: Oral. In one period subjects received 4 capsules of 50 mg of BIA 5-453 after a fasting of at least 10 hours, and in the other period subjects were dosed with 4 capsules of 50 mg of BIA 5-453 after a standard high-fat and high-calorie meal', 'armGroupLabels': ['BIA 5-453 Fasting', 'BIA 5-453 Fed']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'F-35000', 'city': 'Rennes', 'country': 'France', 'facility': "Biotrial's Human Pharmacology Unit", 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bial - Portela C S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}