Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-29 @ 8:06 AM
Study NCT ID:
NCT01181804
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2010-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Safety and Resulting Blood Level Profiles After Administration of a New Boceprevir Tablet Versus Its Current Capsule Formulation for Treatment of Chronic Hepatitis C (P06992)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C512204', 'term': 'N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Vice President, Late Stage Development Group Leader', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication. The sponsor shall have the right to review and comment.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'In this study, participants received two single doses of boceprevir 800 mg, once as capsules and once as tablets, under fed and fasted conditions, in a crossover manner; adverse events were pooled as tablets (fed condition), capsules (fed condition), tablets (fasted condition), or capsules (fasted condition).', 'eventGroups': [{'id': 'EG000', 'title': 'Boceprevir Tablets (Fed)', 'description': 'In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.', 'otherNumAtRisk': 60, 'otherNumAffected': 13, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Boceprevir Capsules (Fed)', 'description': 'In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.', 'otherNumAtRisk': 60, 'otherNumAffected': 6, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Boceprevir Tablets (Fasted)', 'description': 'In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.', 'otherNumAtRisk': 117, 'otherNumAffected': 7, 'seriousNumAtRisk': 117, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Boceprevir Capsules (Fasted)', 'description': 'In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.', 'otherNumAtRisk': 117, 'otherNumAffected': 5, 'seriousNumAtRisk': 117, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Menstruation irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration Curve (AUC) From Hour 0 to the Final Quantifiable Sample (AUCtf) for Boceprevir Tablets Versus Capsules in Fed State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Boceprevir Tablets (Fed)', 'description': 'In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.'}, {'id': 'OG001', 'title': 'Boceprevir Capsules (Fed)', 'description': 'In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '7385', 'groupId': 'OG000', 'lowerLimit': '6939', 'upperLimit': '7859'}, {'value': '6644', 'groupId': 'OG001', 'lowerLimit': '6243', 'upperLimit': '7071'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Least Squares Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.11', 'ciLowerLimit': '1.07', 'ciUpperLimit': '1.15', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of Boceprevir Tablets Versus Capsules in Fed State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Boceprevir Tablets (Fed)', 'description': 'In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.'}, {'id': 'OG001', 'title': 'Boceprevir Capsules (Fed)', 'description': 'In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '2161', 'groupId': 'OG000', 'lowerLimit': '1993', 'upperLimit': '2343'}, {'value': '1515', 'groupId': 'OG001', 'lowerLimit': '1394', 'upperLimit': '1642'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.43', 'ciLowerLimit': '1.32', 'ciUpperLimit': '1.54', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.'}, {'type': 'PRIMARY', 'title': 'AUCtf for Boceprevir Tablets Versus Capsules in Fasted State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Boceprevir Tablets (Fasted)', 'description': 'In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.'}, {'id': 'OG001', 'title': 'Boceprevir Capsules (Fasted)', 'description': 'In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '4329', 'groupId': 'OG000', 'lowerLimit': '4109', 'upperLimit': '4561'}, {'value': '3935', 'groupId': 'OG001', 'lowerLimit': '3734', 'upperLimit': '4146'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.14', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.'}, {'type': 'PRIMARY', 'title': 'Cmax of Boceprevir Tablets Versus Capsules in Fasted State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Boceprevir Tablets (Fasted)', 'description': 'In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.'}, {'id': 'OG001', 'title': 'Boceprevir Capsules (Fasted)', 'description': 'In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '1263', 'groupId': 'OG000', 'lowerLimit': '1196', 'upperLimit': '1333'}, {'value': '1103', 'groupId': 'OG001', 'lowerLimit': '1044', 'upperLimit': '1164'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.15', 'ciLowerLimit': '1.09', 'ciUpperLimit': '1.21', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.'}, {'type': 'PRIMARY', 'title': 'AUC From Hour 0 to Infinity (AUCinf) in Fed State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Boceprevir Tablets (Fed)', 'description': 'In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.'}, {'id': 'OG001', 'title': 'Boceprevir Capsules (Fed)', 'description': 'In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '7457', 'groupId': 'OG000', 'lowerLimit': '7014', 'upperLimit': '7928'}, {'value': '6879', 'groupId': 'OG001', 'lowerLimit': '6467', 'upperLimit': '7318'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.'}, {'type': 'PRIMARY', 'title': 'AUCinf in Fasted State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Boceprevir Tablets (Fasted)', 'description': 'In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.'}, {'id': 'OG001', 'title': 'Boceprevir Capsules (Fasted)', 'description': 'In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '4534', 'groupId': 'OG000', 'lowerLimit': '4285', 'upperLimit': '4798'}, {'value': '4119', 'groupId': 'OG001', 'lowerLimit': '3885', 'upperLimit': '4367'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.'}, {'type': 'PRIMARY', 'title': 'Half Life (t1/2) of Boceprevir in Fed State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Boceprevir Tablets (Fed)', 'description': 'In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.'}, {'id': 'OG001', 'title': 'Boceprevir Capsules (Fed)', 'description': 'In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.61', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'T1/2 is the time required for a given drug concentration to decrease by 50%.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.'}, {'type': 'PRIMARY', 'title': 't1/2 Boceprevir in Fasted State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Boceprevir Tablets (Fasted)', 'description': 'In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.'}, {'id': 'OG001', 'title': 'Boceprevir Capsules (Fasted)', 'description': 'In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.33', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '6.39', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'T1/2 is the time required for a given drug concentration to decrease by 50%.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Boceprevir Tablets Then Capsules ( Fed)', 'description': 'Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.'}, {'id': 'FG001', 'title': 'Boceprevir Capsules Then Tablets ( Fed)', 'description': 'Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.'}, {'id': 'FG002', 'title': 'Boceprevir Tablets Then Capsules (Fasted)', 'description': 'Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir capsules, orally, following and overnight fast.'}, {'id': 'FG003', 'title': 'Boceprevir Capsules Then Tablets (Fasted)', 'description': 'Participants will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir tablets, orally, following and overnight fast.'}], 'periods': [{'title': 'Period 1, Fed (Part 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 2, Fed (Part 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 3, Fasted (Part 2)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 4, Fasted (Part 2)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '177', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Boceprevir Tablets Then Capsules (Fed)', 'description': 'Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.'}, {'id': 'BG001', 'title': 'Boceprevir Capsules Then Tablets (Fed)', 'description': 'Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.'}, {'id': 'BG002', 'title': 'Boceprevir Tablets Then Capsules (Fasted)', 'description': 'Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir capsules, orally, following and overnight fast.'}, {'id': 'BG003', 'title': 'Boceprevir Capsules Then Tablets (Fasted)', 'description': 'Participants will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir tablets, orally, following and overnight fast.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '177', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2010-08-12', 'resultsFirstSubmitDate': '2012-03-23', 'studyFirstSubmitQcDate': '2010-08-12', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-03-23', 'studyFirstPostDateStruct': {'date': '2010-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration Curve (AUC) From Hour 0 to the Final Quantifiable Sample (AUCtf) for Boceprevir Tablets Versus Capsules in Fed State', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Boceprevir Tablets Versus Capsules in Fed State', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.'}, {'measure': 'AUCtf for Boceprevir Tablets Versus Capsules in Fasted State', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.'}, {'measure': 'Cmax of Boceprevir Tablets Versus Capsules in Fasted State', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.'}, {'measure': 'AUC From Hour 0 to Infinity (AUCinf) in Fed State', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.'}, {'measure': 'AUCinf in Fasted State', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.'}, {'measure': 'Half Life (t1/2) of Boceprevir in Fed State', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'T1/2 is the time required for a given drug concentration to decrease by 50%.'}, {'measure': 't1/2 Boceprevir in Fasted State', 'timeFrame': 'Predose through 72 hours post-dose', 'description': 'T1/2 is the time required for a given drug concentration to decrease by 50%.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['boceprevir', 'hepatitis C', 'bioequivalence', 'SCH 503034'], 'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This is a single-dose, randomized, cross-sectional comparison study examining the relative safety and resulting blood level profiles after administration of a new boceprevir tablet formulation versus its current capsule formulation for treatment of chronic hepatitis C. In Part 1 of the study participants will receive boceprevir tablets and capsules under fed conditions. In Part 2 of the study a new group of participants will receive boceprevir tablets and capsules under fasted conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedules.\n* Subjects must be willing to give written informed consent for pharmacogenetic\n\ntesting, and able to adhere to applicable visit schedules.\n\n\\- Subjects of either gender and of any race between the ages of 18 and 65\n\nyears, inclusive, having a Body Mass Index (BMI) between 18 and 32,\n\ninclusive. BMI = weight (kg)/height (m)\\^2. (Individuals with values outside (or\n\nindicate lower or higher) of these ranges may be enrolled if clinically\n\nacceptable to the investigator and sponsor.)\n\n* Subjects' clinical laboratory tests (complete blood count \\[CBC\\], blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator and within an allowed expanded range supplied by sponsor. However, subject's liver function test results (ie, aspartate aminotransferase \\[AST\\], alanine aminotransferase \\[ALT\\]) must not be elevated above normal limits at Screening and on Day -1. No rescreening of liver function tests will be allowed.\n* Subjects must be free of any clinically significant disease that would interfere with the study evaluations.\n* The Screening 12 lead electrocardiogram \\[ECG\\] conduction intervals must be within gender specific normal range (e.g, ECG QTcB,measure in males ≤430 msec and QTcB measure in females ≤450 msec, PR interval ≤200 msec).\n* Vital sign measurements (taken after \\~3 minutes in a sitting position) must be\n\nwithin the following ranges: (Individuals with values outside of these ranges\n\nmay be enrolled if clinically acceptable to the investigator and sponsor.)\n\n1. oral body temperature, between 35.0°C and 37.5°C\n2. systolic blood pressure, 90 to 140 mm Hg\n3. diastolic blood pressure, 45 to 90 mm Hg\n4. pulse rate, 40 to 100 bpm\n\n * Female subjects must be:\n\n<!-- -->\n\n1. postmenopausal (defined as 12 months with no menses, age \\> 40\n\n years and with a follicle-stimulating hormone \\[FSH\\] level of \\>40 u/mL, and serum E2 \\< 73 pmol/L), or\n2. surgically sterilized at least 3 months prior to baseline (eg, documented\n\n hysterectomy or tubal ligation), or\n3. premenopausal and if unsterilized must have used a medically\n\n accepted method of contraception for 3 months (or abstained from\n\n sexual intercourse) prior to the screening period, and agree to use a\n\n medically accepted method of contraception during the trial (including\n\n the screening period prior to receiving trial medication) and for\n\n 2 months after stopping the trial medication. An acceptable method of\n\n contraception includes one of the following:\n\ni. stable oral, transdermal, injectable, or sustained-release vaginal\n\nhormonal contraceptive regimen without breakthrough uterine\n\nbleeding for 3 months prior to Screening; in addition, during\n\nstudy use of condom and/or spermicide (when marketed in the\n\ncountry).\n\nii. intrauterine device (inserted at least 2 months prior to Screening\n\nvisit); in addition, during study use of condom and/or spermicide\n\n(when marketed in the country).\n\niii. condom (male or female) with spermicide (when marketed\n\nwithin the country),\n\niv. diaphragm or cervical cap with spermicide (when marketed\n\nwithin the country) and condom (male),\n\n\\- Non-vasectomized men must agree to use a condom with spermicide or abstain from sexual intercourse, during the trial and for 1 month after stopping the medication.\n\nExclusion Criteria:\n\n* Female subjects who are pregnant, intend to become pregnant (within\n\n 3 months of ending the study), or are breastfeeding.\n* Subjects who, in the opinion of the investigator, will not be able to participate optimally in the study.\n* Any surgical or medical condition which might significantly alter the\n\nabsorption, distribution, metabolism or excretion of any drug. The investigator\n\nshould be guided by evidence of any of the following, and be discussed with\n\nthe sponsor prior to enrollment into the trial:\n\n1. history or presence of inflammatory bowel disease, ulcers,\n\n gastrointestinal or rectal bleeding;\n2. history of major gastrointestinal tract surgery such as gastrectomy,\n\n gastroenterostomy, or bowel resection;\n3. history of pancreatic injury or pancreatitis;\n4. history or presence of liver disease or liver injury;\n5. history or presence of impaired renal function as indicated by clinically\n\n significant elevation in creatinine, blood urea nitrogen \\[BUN\\]/urea, urinary albumin, or\n\n clinically significant urinary cellular constituents ; or\n6. history of urinary obstruction or difficulty in voiding.\n\n \\- Subject who has a history of any infectious disease within 4 weeks prior to\n\n drug administration that in the opinion of the investigator, affects the subject's ability to participate in the trial.\n * Subjects who are positive for hepatitis B surface antigen, hepatitis C\n\n antibodies or human immunodeficiency virus \\[HIV\\].\n\n \\- Subjects who have a positive screen for drugs with a high potential for abuse\n\n (during the Screening period or clinical conduct of the trial).\n\n \\- Subjects with a history of psychiatric or personality disorders that in the\n\n opinion of the investigator and sponsor, affects the subject's ability to\n\n participate in the trial.\n\n \\- Subjects with a history of alcohol or drug abuse in the past 2 years.- Subjects who have donated blood in the past 60 days.\n\n \\- Subjects who have previously received boceprevir.\n * Subjects who are currently participating in another clinical study or have\n\n participated in a clinical study (e.g., laboratory or clinical evaluation) within 30 days of baseline.\n\n \\- Subjects who are part of the study staff personnel or family members of the\n\n study staff personnel.\n * Subjects who have demonstrated allergic reactions (eg, food, drug, atopic\n\n reactions or asthmatic episodes) which, in the opinion of the investigator and\n\n sponsor, interfere with their ability to participate in the trial.\n\n \\- Subjects who smoke more than 10 cigarettes or equivalent tobacco use per\n\n day.\n * Subjects who have a history of malignancy.\n * Subjects who have received any prohibited treatment (prescription and non prescription medication except acetaminophen, potent inhibitors and inducers of cytochrome P3A \\[CYP3A4\\], or vitamins and herbals) more recently than the indicated washout period prior to Randomization which, in the opinion of the investigator and sponsor, interferes with their ability to participate in the trial."}, 'identificationModule': {'nctId': 'NCT01181804', 'briefTitle': 'Comparison of Safety and Resulting Blood Level Profiles After Administration of a New Boceprevir Tablet Versus Its Current Capsule Formulation for Treatment of Chronic Hepatitis C (P06992)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Definitive Bioequivalence Study of a New Boceprevir (SCH 503034) Tablet Formulation Compared to the Current Capsule Form in Healthy Male and Female Subjects.', 'orgStudyIdInfo': {'id': 'P06992'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Boceprevir Tablets then Capsules (fed)', 'description': 'Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.', 'interventionNames': ['Drug: boceprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Boceprevir Capsules then tablets (fed)', 'description': 'Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.', 'interventionNames': ['Drug: boceprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Boceprevir Tablets then Capsules (fasted)', 'description': 'Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast, and then 4 days later will take a single dose of boceprevir capsules, orally, following an overnight fast.', 'interventionNames': ['Drug: boceprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Boceprevir Capsules then Tablets (fasted)', 'description': 'Participants on this study arm will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast, and then 4 days later will take a single dose of boceprevir tablets, orally, following an overnight fast.', 'interventionNames': ['Drug: boceprevir']}], 'interventions': [{'name': 'boceprevir', 'type': 'DRUG', 'otherNames': ['SCH 503034'], 'description': 'Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.', 'armGroupLabels': ['Boceprevir Tablets then Capsules (fed)']}, {'name': 'boceprevir', 'type': 'DRUG', 'otherNames': ['SCH 503034'], 'description': 'Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.', 'armGroupLabels': ['Boceprevir Capsules then tablets (fed)']}, {'name': 'boceprevir', 'type': 'DRUG', 'otherNames': ['SCH 503034'], 'description': 'Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.', 'armGroupLabels': ['Boceprevir Tablets then Capsules (fasted)']}, {'name': 'boceprevir', 'type': 'DRUG', 'otherNames': ['SCH 503034'], 'description': 'Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.', 'armGroupLabels': ['Boceprevir Capsules then Tablets (fasted)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}