Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-27 @ 9:23 PM
Study NCT ID:
NCT01605461
Status:
COMPLETED
Last Update Posted:
2016-03-21
First Post:
2012-05-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From drug administration until end of study examination, up to 14 days', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.', 'otherNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Vessel puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC0-infinity of Plasma Deleobuvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.'}], 'classes': [{'categories': [{'measurements': [{'value': '19300', 'spread': '56.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Area under the plasma deleobuvir concentration-time curve over the time interval from 0 h extrapolated to infinity (AUC0-infinity)', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PK set) which included all subjects in the treated set who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.'}, {'type': 'PRIMARY', 'title': 'Cmax of Plasma Deleobuvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.'}], 'classes': [{'categories': [{'measurements': [{'value': '3620', 'spread': '54.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Maximum measured concentration (Cmax) of plasma deleobuvir', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'PRIMARY', 'title': 't1/2 of [14C]-Radioactivity in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.89', 'spread': '36.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Terminal half life (T1/2) of \\[14C\\]-radioactivity in plasma', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'PRIMARY', 'title': 'Excretion Balance of Total [14C]-Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.2', 'spread': '1.29', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration', 'description': 'Excretion balance of total \\[14C\\]-radioactivity (urine and faeces)', 'unitOfMeasure': 'Percentage of radioactive dose recovered', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'PRIMARY', 'title': 'Excretion of Total [14C]-Radioactivity in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.137', 'spread': '37.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration', 'description': 'Excretion of total \\[14C\\]-radioactivity in urine', 'unitOfMeasure': 'Percentage of radioactive dose recovered', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'PRIMARY', 'title': 'Excretion of Total [14C]-Radioactivity in Faeces', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.1', 'spread': '1.29', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration', 'description': 'Excretion of total \\[14C\\]-radioactivity in faeces', 'unitOfMeasure': 'Percentage of radioactive dose recovered', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'spread': '11.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set which included all subjects who were dispensed study medication and were documented to have taken the dose of investigational treatment'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-22', 'studyFirstSubmitDate': '2012-05-09', 'resultsFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2012-05-21', 'lastUpdatePostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-22', 'studyFirstPostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-infinity of Plasma Deleobuvir', 'timeFrame': '15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Area under the plasma deleobuvir concentration-time curve over the time interval from 0 h extrapolated to infinity (AUC0-infinity)'}, {'measure': 'Cmax of Plasma Deleobuvir', 'timeFrame': '15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Maximum measured concentration (Cmax) of plasma deleobuvir'}, {'measure': 't1/2 of [14C]-Radioactivity in Plasma', 'timeFrame': '15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration', 'description': 'Terminal half life (T1/2) of \\[14C\\]-radioactivity in plasma'}, {'measure': 'Excretion Balance of Total [14C]-Radioactivity', 'timeFrame': 'Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration', 'description': 'Excretion balance of total \\[14C\\]-radioactivity (urine and faeces)'}, {'measure': 'Excretion of Total [14C]-Radioactivity in Urine', 'timeFrame': 'Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration', 'description': 'Excretion of total \\[14C\\]-radioactivity in urine'}, {'measure': 'Excretion of Total [14C]-Radioactivity in Faeces', 'timeFrame': 'Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration', 'description': 'Excretion of total \\[14C\\]-radioactivity in faeces'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Phase 1 study to assess the pharmacokinetics and routes of elimination of a single oral dose of \\[14C\\]-BI 207127 and to characterize the metabolic profile following single dose administration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Body mass index =18.5 and BMI = 29.9 kg/m2\n* Subject is willing to avoid sun exposure from the first administration of the trial drug until the end of the study\n* Male subjects must agree to minimise the risk of female partners becoming pregnant from the dosing day until three months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than three months prior to dosing or barrier contraception. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device, tubal ligation, or hormonal contraceptive for at least three months, or diaphragm with spermicide.\n* Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.\n\nExclusion criteria:\n\n* Participation in more than one other radiolabelled investigational study drug trial within 12 months prior to check-in. The previous radiolabelled study drug must have been received more than 6 months prior to check-in for this study and the total exposure from this study and the previous study will be within the recommended levels considered safe, per 21 CFR 361.1 (eg. less than 5,000 mrem whole body annual exposure)\n* Exposure to significant radiation (eg. serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to check-in\n* Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial\n* Use of drugs which might reasonably influence the results of the trial, including use of a broad spectrum antibiotic, within 10 days prior to administration of investigational medication in this trial or during the trial\n* Intake of a drug with a half-life of \\>24 hours within the month prior to administration of trial medication, or if administration of trial medication would occur in the time period in which fewer than 10 half-lives had elapsed\n* Surgery of the gastrointestinal tract (except appendectomy or cholecystectomy)\n* Current smoker or smoker in last six months; alcohol abuse (more than 40 g/day); history of illicit drug abuse within the past 2 years\n* Blood donation (more than 100 mL within four weeks prior to first administration of the trial drug or during the trial)\n* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \\>450 ms); a history of additional risk factors for torsades de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)\n* History of photosensitivity or recurrent rash\n* Irregular defecation pattern (less than one bowel movement a day)'}, 'identificationModule': {'nctId': 'NCT01605461', 'briefTitle': 'Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Metabolite Profile, Excretion Balance and Pharmacokinetics of BI 207127 NA Combined With [14C]-BI 207127 NA in Healthy Adult Male Volunteers After an 800 mg Single Oral Solution Dose; a Phase I, Single-arm, Open-label Trial', 'orgStudyIdInfo': {'id': '1241.22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 207127 NA', 'description': 'Single oral solution dose of BI 207127 NA combined with \\[14C\\]-BI 207127 NA', 'interventionNames': ['Drug: BI 207127 NA']}], 'interventions': [{'name': 'BI 207127 NA', 'type': 'DRUG', 'description': 'Single oral solution dose of BI 207127 NA combined with \\[14C\\]-BI 207127 NA', 'armGroupLabels': ['BI 207127 NA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': '1241.22.001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}