Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-03-02 @ 8:05 AM
Study NCT ID:
NCT02218294
Status:
COMPLETED
Last Update Posted:
2014-10-29
First Post:
2014-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine How BCX4161 is Metabolized and Eliminated by the Body
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054179', 'term': 'Angioedemas, Hereditary'}], 'ancestors': [{'id': 'D000799', 'term': 'Angioedema'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000081208', 'term': 'Hereditary Complement Deficiency Diseases'}, {'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722673', 'term': 'avoralstat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-27', 'studyFirstSubmitDate': '2014-08-14', 'studyFirstSubmitQcDate': '2014-08-14', 'lastUpdatePostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mass balance of BCX4161 after a single oral dose of [14C] BCX4161 based upon radioactivity excreted in urine, expired air and feces', 'timeFrame': 'Determined from samples drawn up to 14 days post-dose'}], 'secondaryOutcomes': [{'measure': 'Chemical structure elucidation of major metabolites of [14C] BCX4161 in urine, plasma, feces, urine', 'timeFrame': 'Determined from samples drawn up to 4 days post-dose'}, {'measure': 'Plasma pharmacokinetics (Cmax, Tmax, Tlag, AUC(0-last), AUC(0-inf), CL/F, Vz/F, AUC%extrapolated,t1/2, as applicable for each analyte) of total radioactivity, BCX4161, [14C] BCX4161 and major metabolites of [14C] BCX4161', 'timeFrame': 'Data generated from samples drawn up to 7 days post-dose'}, {'measure': 'Urinary pharmacokinetics (CLr, Ae, and % dose excreted) of BCX4161', 'timeFrame': 'Data generated from samples drawn up to 7 days post-dose'}, {'measure': 'Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations', 'timeFrame': 'Over the duration of the study, approximately 6 weeks from screening through follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BCX4161', 'BioCryst', 'hereditary angioedema', 'mass balance', 'kallikrein inhibitor', 'ADME'], 'conditions': ['Hereditary Angioedema']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made by the body, the chemical composition of these metabolites and their profile over time in blood and urine will be determined.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy males\n2. Age 30 to 65 years of age (inclusive)\n3. Body mass index of 18.0 to 32.0 kg/m2\n4. Must be willing and able to communicate and participate in the whole study\n5. Must provide written informed consent\n6. A history of regular bowel movements\n7. Must agree to use an adequate method of contraception\n\nKey Exclusion Criteria:\n\n1. Participation in a clinical research study within the previous 3 months\n2. Current or history of any drug or alcohol abuse in the past 2 years or positive drugs of abuse screen\n3. Current smokers\n4. Radiation exposure, including that from the present study, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years\n5. Clinically significant medical history, current medical or psychiatric condition, ECG finding, or laboratory/urinalysis abnormality\n6. Activated partial thromboplastin time or PT outside of normal laboratory limits'}, 'identificationModule': {'nctId': 'NCT02218294', 'briefTitle': 'Study to Determine How BCX4161 is Metabolized and Eliminated by the Body', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioCryst Pharmaceuticals'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Absorption, Metabolism and Excretion of BCX4161 Following Administration of a Single, Oral Dose of [14C]-Radiolabelled BCX4161 to Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'BCX4161-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C] BCX4161', 'description': 'Includes a radiolabelled dose of \\[14C\\] BCX4161 and unlabelled BCX4161', 'interventionNames': ['Drug: BCX4161']}], 'interventions': [{'name': 'BCX4161', 'type': 'DRUG', 'armGroupLabels': ['[14C] BCX4161']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Ruddington', 'state': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Clinical Ltd', 'geoPoint': {'lat': 52.89254, 'lon': -1.14953}}], 'overallOfficials': [{'name': 'Joanne Collier, MBChB, FFPM, Dip Stats (OU)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quotient Clinical Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioCryst Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}