Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-28 @ 12:02 AM
Study NCT ID:
NCT04991194
Status:
TERMINATED
Last Update Posted:
2021-08-05
First Post:
2021-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Age-gender on the Pharmacokinetic and Pharmacodynamic Profiles of BIA 5 1058
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630084', 'term': 'zamicastat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to 4 weeks', 'description': 'Pharmacokinetic analysis\n\nBlood samples for PK analysis were taken at the following times:\n\nOn D1: before BIA 5-1058 dosing (pre-dose), and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h post-dose (before the second administration on D2).\n\nOn D3, D7, D8 and D9: before BIA 5-1058 dosing. From D10 to D13: before BIA 5-1058 dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (D11), 36 (D11), 48 (D12), 60 (D12) and 72h post-dose (D13).'}, {'measure': 'Time of occurrence of Cmax (tmax)', 'timeFrame': 'Up to 4 weeks', 'description': 'Pharmacokinetic analysis\n\nBlood samples for PK analysis were taken at the following times:\n\nOn D1: before BIA 5-1058 dosing (pre-dose), and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h post-dose (before the second administration on D2).\n\nOn D3, D7, D8 and D9: before BIA 5-1058 dosing. From D10 to D13: before BIA 5-1058 dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (D11), 36 (D11), 48 (D12), 60 (D12) and 72h post-dose (D13).'}, {'measure': 'Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which the drug concentration was at or above the lower limit of quantification (AUC0-t)', 'timeFrame': 'Up to 4 weeks', 'description': 'Pharmacokinetic analysis\n\nBlood samples for PK analysis were taken at the following times:\n\nOn D1: before BIA 5-1058 dosing (pre-dose), and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h post-dose (before the second administration on D2).\n\nOn D3, D7, D8 and D9: before BIA 5-1058 dosing. From D10 to D13: before BIA 5-1058 dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (D11), 36 (D11), 48 (D12), 60 (D12) and 72h post-dose (D13).'}, {'measure': 'Area under the plasma concentration-time curve from time zero to 24 hours after last dosing (AUC0-24)', 'timeFrame': 'Up to 4 weeks', 'description': 'Pharmacokinetic analysis\n\nBlood samples for PK analysis were taken at the following times:\n\nOn D1: before BIA 5-1058 dosing (pre-dose), and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h post-dose (before the second administration on D2).\n\nOn D3, D7, D8 and D9: before BIA 5-1058 dosing. From D10 to D13: before BIA 5-1058 dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (D11), 36 (D11), 48 (D12), 60 (D12) and 72h post-dose (D13).'}, {'measure': 'Apparent terminal half-life (t½)', 'timeFrame': 'Up to 4 weeks', 'description': 'Pharmacokinetic analysis\n\nBlood samples for PK analysis were taken at the following times:\n\nOn D1: before BIA 5-1058 dosing (pre-dose), and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h post-dose (before the second administration on D2).\n\nOn D3, D7, D8 and D9: before BIA 5-1058 dosing. From D10 to D13: before BIA 5-1058 dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (D11), 36 (D11), 48 (D12), 60 (D12) and 72h post-dose (D13).'}, {'measure': 'Apparent total body clearance (CL/F)', 'timeFrame': 'Up to 4 weeks', 'description': 'Pharmacokinetic analysis\n\nBlood samples for PK analysis were taken at the following times:\n\nOn D1: before BIA 5-1058 dosing (pre-dose), and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h post-dose (before the second administration on D2).\n\nOn D3, D7, D8 and D9: before BIA 5-1058 dosing. From D10 to D13: before BIA 5-1058 dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (D11), 36 (D11), 48 (D12), 60 (D12) and 72h post-dose (D13).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'the purpose of this study is to determine the effect of age on the Pharmacokinetics (PK) profile of BIA 5-1058 at steady state after multiple oral doses', 'detailedDescription': 'This was a single-centre, open-label, parallel group, non-randomised, two-part multiple dose 10-day study in healthy young and elderly male and female subjects. The study comprised a screening evaluation between 2 and 28 days before the first Investigational Medicinal Product (IMP) administration, a hospitalisation period of 15 days comprising a treatment period of 10 days, and a follow-up visit approximately 7 days after discharge.\n\nPart 1: Subjects received 1200 mg of BIA 5-1058 once a day (od), in fasting conditions, for 10 days Part 2 : Subjects received 400 mg of BIA 5-1058 od, in fasting conditions, for 10 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll subjects (young and elderly):\n\n1. A signed and dated informed consent form before any study-specific screening procedure was performed;\n2. Healthy male and female subjects as determined by the Investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ECG);\n3. Non-smoker or ex-smokers for at least 3 months at screening;\n4. BMI between 18 and 30 kg/m2, inclusive;\n5. Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibodies (HCV Ab) and anti-human immunodeficiency virus antibodies (HIV-1 and HIV-2 Ab) at screening;\n6. Clinical laboratory test results clinically acceptable at screening and admission to the study;\n7. Negative screen for alcohol and drugs of abuse at screening and admission to the study;\n\n If male:\n8. Using an effective method of contraception with a pregnant partner or partner of childbearing potential (condom or occlusive cap \\[diaphragm or cervical or vault caps\\] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomy) throughout the study;\n9. Refraining from donating sperm throughout the study.\n\n Young subjects only:\n10. Males and females aged between 18 and 40 years, inclusive.\n\n If female:\n11. No childbearing potential by reason of surgery or at least 1 year post-menopause (i.e., 12 months post last menstrual period), or menopause confirmed by follicle-stimulating hormone (FSH) testing;\n12. If of childbearing potential, using an effective non-hormonal method of contraception \\[intrauterine device or intrauterine system; condom or occlusive cap (diaphragm or cervical or vault caps) with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he is the sole partner of that subject\\] for all the duration of the study;\n13. If of childbearing potential, negative serum pregnancy test at screening and negative urine pregnancy test on admission to the study.\n\n Elderly subjects only:\n14. Males and females older than 65 years, inclusive.\n\nExclusion Criteria:\n\nAll subjects (young and elderly):\n\n1. 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;\n2. Clinically relevant surgical history;\n3. History of relevant atopy or drug hypersensitivity;\n4. History of alcoholism or drug abuse;\n5. Consumption of more than 14 units of alcohol a week \\[1 unit corresponds to 1 glass of 12° wine (10 cL), 1 glass of 45° pastis (2.5 cL), 1 glass of 40° whisky (2.5 cL), 1 glass of 12° champagne (10 cL), 1 glass of 18°aperitif drink (7 cL) or one 25-cL glass of 5°beer\\];\n6. Significant infection or known inflammatory process at screening or admission to study;\n7. Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the study;\n8. Previous use of BIA 5-1058;\n9. Use of any investigational drug or participation in any clinical trial within 90 days prior to screening;\n10. Participation in more than 2 clinical trials within the 12 months prior to screening;\n11. Donation or reception of any blood or blood products within the 3 months prior to screening;\n12. Vegetarians, vegans or other medical dietary restrictions;\n13. Not able to communicate reliably with the Investigator;\n14. Unlikely to co-operate with the requirements of the study.\n\n If male:\n15. Not using an accepted effective method of contraception;\n16. Refusing to refrain from donating sperm throughout the study.\n\n Young subjects only:\n17. Use of medicines within 2 weeks of admission that could affect the safety or other study assessments, in the Investigator's opinion;\n\n If female of childbearing potential:\n18. Pregnant or breastfeeding;\n19. Not using an accepted effective contraceptive method or using oral contraceptives.\n\n Elderly subjects only:\n20. For elderly subjects, previously prescribed medications that interfered with absorption, distribution, metabolism, and excretion or safety/tolerability evaluation of BIA 5-1058 and adrenal or renal function were prohibited; however, previously prescribed medications that did not interfere with absorption, distribution, metabolism, and excretion or safety/tolerability evaluation of BIA 5-1058, adrenal or renal function and which could not interfere with the objectives of the study were allowed if the dose regimen had been stable for at least 4 weeks and was expected to remain stable throughout the study. Such concomitant medications were to be reviewed and mutually agreed upon by the Sponsor and the Investigator."}, 'identificationModule': {'nctId': 'NCT04991194', 'briefTitle': 'Effect of Age-gender on the Pharmacokinetic and Pharmacodynamic Profiles of BIA 5 1058', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bial - Portela C S.A.'}, 'officialTitle': 'Effect of Age-gender on the Pharmacokinetic and Pharmacodynamic Profiles of BIA 5 1058. An Open-label, Parallel Group, Multiple Dose 10-day Study.', 'orgStudyIdInfo': {'id': 'BIA-51058-105'}, 'secondaryIdInfos': [{'id': '2015-003682-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIA 5-1058 1200 mg (Part I)', 'description': 'Subjects received 1200 mg of BIA 5-1058 once a day (od), in fasting conditions, for 10 days', 'interventionNames': ['Drug: BIA 5-1058']}, {'type': 'EXPERIMENTAL', 'label': 'BIA 5-1058 400 mg (Part II)', 'description': 'Subjects received 400 mg of BIA 5-1058 od, in fasting conditions, for 10 days.', 'interventionNames': ['Drug: BIA 5-1058']}], 'interventions': [{'name': 'BIA 5-1058', 'type': 'DRUG', 'otherNames': ['Zamicastat'], 'description': 'Each subject was administered either 1200 mg (Part 1) or 400 mg (Part 2) BIA 5-1058 od for 10 days, in fasting conditions for 8 hours \\[Day (D)2 to D9\\] or 10 hours (D1 and D13), and remained fasted for 2 hours (D2 to D9) or 4 hours (D1 and D13) post-dose. The formulation was tablets 100 mg and the mode of administration was oral.', 'armGroupLabels': ['BIA 5-1058 1200 mg (Part I)', 'BIA 5-1058 400 mg (Part II)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bial - Portela C S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}