Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-17 @ 3:14 PM
Study NCT ID:
NCT01465412
Status:
COMPLETED
Last Update Posted:
2018-09-24
First Post:
2011-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C539997', 'term': '2-(2-furanyl)-7-(2-(4-(4-(2-methoxyethoxy)phenyl)-1-piperazinyl)ethyl)-7H-pyrazolo(4,3-e)(1,2,4)triazolo(1,5-c)pyrimidine-5-amine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with regard to proprietary information; the accuracy of the information; and to ensure that the presentation is fairly balanced and in compliance with Food and Drug Administration (FDA) regulations.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 7 days', 'description': 'All participants who received an oral dose of preladenant.', 'eventGroups': [{'id': 'EG000', 'title': 'Mild Hepatic Impaired (HI) Part 1', 'description': 'Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.', 'otherNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy to Match Mild HI Part 1', 'description': 'Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Moderate HI Part 2', 'description': 'Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.', 'otherNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Healthy to Match Moderate HI Part 2', 'description': 'Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.', 'otherNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUC 0-t) of Preladenant After a Single Dose of Preladenant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatic Impaired (HI) Part 1', 'description': 'Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG001', 'title': 'Healthy to Match Mild HI Part 1', 'description': 'Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG002', 'title': 'Moderate HI Part 2', 'description': 'Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG003', 'title': 'Healthy to Match Moderate HI Part 2', 'description': 'Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.864', 'groupId': 'OG000', 'lowerLimit': '33.181', 'upperLimit': '304.594'}, {'value': '91.014', 'groupId': 'OG001', 'lowerLimit': '27.457', 'upperLimit': '171.810'}, {'value': '300.667', 'groupId': 'OG002', 'lowerLimit': '81.081', 'upperLimit': '571.197'}, {'value': '115.715', 'groupId': 'OG003', 'lowerLimit': '16.816', 'upperLimit': '352.507'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.075', 'ciLowerLimit': '0.695', 'ciUpperLimit': '1.662', 'groupDescription': 'The analysis was performed using an analysis of covariance (ANCOVA) model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, Body Mass Index (BMI) and a categorical covariate, gender. Gender was excluded from Part 1 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the least squares mean (LSM) Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.598', 'ciLowerLimit': '1.334', 'ciUpperLimit': '5.060', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Preladenant After a Single Dose of Preladenant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatic Impaired (HI) Part 1', 'description': 'Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG001', 'title': 'Healthy to Match Mild HI Part 1', 'description': 'Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG002', 'title': 'Moderate HI Part 2', 'description': 'Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG003', 'title': 'Healthy to Match Moderate HI Part 2', 'description': 'Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.380', 'groupId': 'OG000', 'lowerLimit': '15.900', 'upperLimit': '61.500'}, {'value': '30.171', 'groupId': 'OG001', 'lowerLimit': '5.890', 'upperLimit': '73.200'}, {'value': '56.997', 'groupId': 'OG002', 'lowerLimit': '8.950', 'upperLimit': '109.00'}, {'value': '39.735', 'groupId': 'OG003', 'lowerLimit': '4.130', 'upperLimit': '113.00'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.305', 'ciLowerLimit': '0.840', 'ciUpperLimit': '2.027', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.434', 'ciLowerLimit': '0.643', 'ciUpperLimit': '3.198', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.'}, {'type': 'SECONDARY', 'title': 'AUC 0-t of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatic Impaired (HI) Part 1', 'description': 'Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG001', 'title': 'Healthy to Match Mild HI Part 1', 'description': 'Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG002', 'title': 'Moderate HI Part 2', 'description': 'Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG003', 'title': 'Healthy to Match Moderate HI Part 2', 'description': 'Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.505', 'groupId': 'OG000', 'lowerLimit': '17.858', 'upperLimit': '60.434'}, {'value': '15.395', 'groupId': 'OG001', 'lowerLimit': '0.156', 'upperLimit': '45.462'}, {'value': '60.486', 'groupId': 'OG002', 'lowerLimit': '17.213', 'upperLimit': '96.253'}, {'value': '25.288', 'groupId': 'OG003', 'lowerLimit': '6.399', 'upperLimit': '149.982'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.852', 'ciLowerLimit': '0.810', 'ciUpperLimit': '4.234', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.392', 'ciLowerLimit': '1.306', 'ciUpperLimit': '4.382', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of SCH 434748.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.'}, {'type': 'SECONDARY', 'title': 'Cmax of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatic Impaired (HI) Part 1', 'description': 'Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG001', 'title': 'Healthy to Match Mild HI Part 1', 'description': 'Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG002', 'title': 'Moderate HI Part 2', 'description': 'Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG003', 'title': 'Healthy to Match Moderate HI Part 2', 'description': 'Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.503', 'groupId': 'OG000', 'lowerLimit': '5.280', 'upperLimit': '20.400'}, {'value': '6.784', 'groupId': 'OG001', 'lowerLimit': '0.624', 'upperLimit': '21.400'}, {'value': '13.983', 'groupId': 'OG002', 'lowerLimit': '4.530', 'upperLimit': '52.700'}, {'value': '9.936', 'groupId': 'OG003', 'lowerLimit': '2.970', 'upperLimit': '54.500'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.548', 'ciLowerLimit': '0.918', 'ciUpperLimit': '2.610', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.407', 'ciLowerLimit': '0.720', 'ciUpperLimit': '2.750', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of SCH 434748.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.'}, {'type': 'SECONDARY', 'title': 'AUC 0-t of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatic Impaired (HI) Part 1', 'description': 'Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG001', 'title': 'Healthy to Match Mild HI Part 1', 'description': 'Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG002', 'title': 'Moderate HI Part 2', 'description': 'Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG003', 'title': 'Healthy to Match Moderate HI Part 2', 'description': 'Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.262', 'groupId': 'OG000', 'lowerLimit': '18.636', 'upperLimit': '87.772'}, {'value': '24.612', 'groupId': 'OG001', 'lowerLimit': '0.149', 'upperLimit': '84.837'}, {'value': '170.215', 'groupId': 'OG002', 'lowerLimit': '55.366', 'upperLimit': '491.013'}, {'value': '35.421', 'groupId': 'OG003', 'lowerLimit': '10.783', 'upperLimit': '70.257'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.555', 'ciLowerLimit': '0.617', 'ciUpperLimit': '3.917', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.806', 'ciLowerLimit': '2.770', 'ciUpperLimit': '8.335', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of SCH 446637.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.'}, {'type': 'SECONDARY', 'title': 'Cmax of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatic Impaired (HI) Part 1', 'description': 'Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG001', 'title': 'Healthy to Match Mild HI Part 1', 'description': 'Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG002', 'title': 'Moderate HI Part 2', 'description': 'Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG003', 'title': 'Healthy to Match Moderate HI Part 2', 'description': 'Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.691', 'groupId': 'OG000', 'lowerLimit': '6.470', 'upperLimit': '29.100'}, {'value': '10.004', 'groupId': 'OG001', 'lowerLimit': '0.595', 'upperLimit': '24.000'}, {'value': '21.761', 'groupId': 'OG002', 'lowerLimit': '9.840', 'upperLimit': '45.600'}, {'value': '10.993', 'groupId': 'OG003', 'lowerLimit': '4.910', 'upperLimit': '21.400'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.269', 'ciLowerLimit': '0.703', 'ciUpperLimit': '2.288', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.980', 'ciLowerLimit': '1.316', 'ciUpperLimit': '2.977', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of SCH 446637.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.'}, {'type': 'SECONDARY', 'title': 'AUC 0-t of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatic Impaired (HI) Part 1', 'description': 'Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG001', 'title': 'Healthy to Match Mild HI Part 1', 'description': 'Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG002', 'title': 'Moderate HI Part 2', 'description': 'Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG003', 'title': 'Healthy to Match Moderate HI Part 2', 'description': 'Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.605', 'groupId': 'OG000', 'lowerLimit': '0.547', 'upperLimit': '6.396'}, {'value': '1.211', 'groupId': 'OG001', 'lowerLimit': '0.261', 'upperLimit': '3.295'}, {'value': '6.792', 'groupId': 'OG002', 'lowerLimit': '1.133', 'upperLimit': '15.708'}, {'value': '1.681', 'groupId': 'OG003', 'lowerLimit': '0.202', 'upperLimit': '6.757'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.326', 'ciLowerLimit': '0.749', 'ciUpperLimit': '2.348', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.041', 'ciLowerLimit': '1.460', 'ciUpperLimit': '11.187', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant calculated using free drug concentration.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.'}, {'type': 'SECONDARY', 'title': 'Cmax of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatic Impaired (HI) Part 1', 'description': 'Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG001', 'title': 'Healthy to Match Mild HI Part 1', 'description': 'Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG002', 'title': 'Moderate HI Part 2', 'description': 'Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'OG003', 'title': 'Healthy to Match Moderate HI Part 2', 'description': 'Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.646', 'groupId': 'OG000', 'lowerLimit': '0.223', 'upperLimit': '1.412'}, {'value': '0.401', 'groupId': 'OG001', 'lowerLimit': '0.130', 'upperLimit': '1.129'}, {'value': '1.288', 'groupId': 'OG002', 'lowerLimit': '0.255', 'upperLimit': '2.787'}, {'value': '0.577', 'groupId': 'OG003', 'lowerLimit': '0.050', 'upperLimit': '2.184'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.609', 'ciLowerLimit': '1.007', 'ciUpperLimit': '2.572', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.231', 'ciLowerLimit': '0.844', 'ciUpperLimit': '5.896', 'groupDescription': 'The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \\[0.50, 2.00\\].'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant calculated using free drug concentration.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mild Hepatic Impaired (HI) Part 1', 'description': 'Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'FG001', 'title': 'Healthy to Match Mild HI Part 1', 'description': 'Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'FG002', 'title': 'Moderate HI Part 2', 'description': 'Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'FG003', 'title': 'Healthy to Match Moderate HI Part 2', 'description': 'Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Mild Hepatic Impaired (HI) Part 1', 'description': 'Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'BG001', 'title': 'Healthy to Match Mild HI Part 1', 'description': 'Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'BG002', 'title': 'Moderate HI Part 2', 'description': 'Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'BG003', 'title': 'Healthy to Match Moderate HI Part 2', 'description': 'Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.3', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '52.3', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '52.2', 'spread': '4.8', 'groupId': 'BG002'}, {'value': '50.1', 'spread': '3.3', 'groupId': 'BG003'}, {'value': '52.7', 'spread': '5.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2012-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-24', 'studyFirstSubmitDate': '2011-10-28', 'resultsFirstSubmitDate': '2016-03-08', 'studyFirstSubmitQcDate': '2011-11-01', 'lastUpdatePostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-08', 'studyFirstPostDateStruct': {'date': '2011-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUC 0-t) of Preladenant After a Single Dose of Preladenant', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Preladenant After a Single Dose of Preladenant', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant.'}], 'secondaryOutcomes': [{'measure': 'AUC 0-t of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of SCH 434748.'}, {'measure': 'Cmax of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of SCH 434748.'}, {'measure': 'AUC 0-t of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of SCH 446637.'}, {'measure': 'Cmax of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of SCH 446637.'}, {'measure': 'AUC 0-t of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant calculated using free drug concentration.'}, {'measure': 'Cmax of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant', 'timeFrame': 'Pre-dose up to 72 hours postdose', 'description': 'For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant calculated using free drug concentration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parkinson disease'], 'conditions': ['Chronic Hepatic Impairment']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after administration of a single 5 mg oral dose of preladenant in participants with hepatic impairment and healthy volunteers. Part 1 of this study compares healthy volunteers with participants with mild hepatic impairment. Part 2 compares healthy volunteers with participants with moderate hepatic impairment. Healthy volunteers in each part of this study are to be matched with participants with hepatic impairment by race, age, gender, and body mass index (BMI). The primary hypotheses are that in participants with mild or moderate HI, the area under the concentration-time curve from time 0 extrapolated to time of the last quantifiable concentration (AUC0-t) of preladenant is similar to that observed in matched healthy volunteers, so that the mean ratio of hepatic impaired/healthy is contained within the interval \\[0.50, 2.00\\].'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria for Healthy Participants Groups:\n\n* Must be healthy with normal hepatic function and be free of any clinically significant disease or condition that requires a physician's care and/or would interfere with study evaluations or procedures.\n\nKey Inclusion Criteria for Hepatic Impaired Groups:\n\n* Must have mild or moderate hepatic impairment.\n* Must have a diagnosis of chronic liver disease for \\>6 months.\n* Clinical laboratory tests, physical examination, and electrocardiographs must be clinically acceptable to the investigator and sponsor.\n* Must be free, other than chronic liver disease, of significant medical conditions unrelated to their hepatic disorder except for conditions that in the opinion of the investigator may not interfere with the study evaluations, procedures or participation.\n\nKey Exclusion Criteria\n\n* Must not be on any prohibited medications for entry into the trial."}, 'identificationModule': {'nctId': 'NCT01465412', 'briefTitle': 'A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-label, Single Dose, Oral Administration, Sequential Two Parts Study to Compare the Pharmacokinetics of SCH 420814 / MK-3814 in Subjects With Mild and Moderate Chronic Hepatic Impairment With Their Respectively Matching Healthy Volunteers', 'orgStudyIdInfo': {'id': 'P06513'}, 'secondaryIdInfos': [{'id': 'MK-3814-034', 'type': 'OTHER', 'domain': 'Merck & Co.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild Hepatic Impaired (HI) Part 1', 'description': 'Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.', 'interventionNames': ['Drug: Preladenant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy to Match Mild HI Part 1', 'description': 'Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.', 'interventionNames': ['Drug: Preladenant']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate HI Part 2', 'description': 'Participants with moderate chronic liver disease enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.', 'interventionNames': ['Drug: Preladenant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy to Match Moderate HI Part 2', 'description': 'Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.', 'interventionNames': ['Drug: Preladenant']}], 'interventions': [{'name': 'Preladenant', 'type': 'DRUG', 'otherNames': ['SCH 420814', 'MK-3814', 'Adenosine 2a Antagonist'], 'description': 'After at least an 8 hours overnight fast, one 5-mg preladenant tablet, is administered orally, on Day 1.', 'armGroupLabels': ['Healthy to Match Mild HI Part 1', 'Healthy to Match Moderate HI Part 2', 'Mild Hepatic Impaired (HI) Part 1', 'Moderate HI Part 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}